Navigating Regulatory Compliance: A Deep Dive Into QMS Compliance for Medical Devices

Join this comprehensive exploration of the ever-evolving landscape of quality management system (QMS) compliance within the medical device industry. This webinar is crafted to offer valuable insights on achieving and sustaining compliance across the product development lifecycle for regulations such as FDA, ISO, and EU MDR. By the session’s conclusion, participants will acquire actionable insights and best practices to refine their regulatory compliance strategies, navigating the intricate landscape of various QMS requirements with confidence and efficiency.

Through real-world examples and case studies, we will address key challenges faced by medical device companies in meeting regulatory standards.

Full transcript below:

Tom Salemi

Hey everybody, this is Tom Salemi of DeviceTalks. Welcome to our very first episode of DeviceTalks Tuesdays in 2024. It’s great to have you back. It’s great to be here. We’ve missed you all, but we’ve got a rock-solid lineup of presentations over the next 12 months. Make sure you keep an eye on devicetalks.com on all that’s coming up. Today, I’m really excited to bring in our sponsor, Arena. They’ve got a presentation here, Navigating Regulatory Compliance: A Deep Dive Into QMS Compliance for Medical Devices.

So, before we begin this, I’m just going to go over a few ground rules. We have our new snazzy title slide. I got a snazzy backdrop for myself, although we may be updating that, but it’s pretty cool. So, all the material you’ll need to follow along is available in the resource widgets at the bottom of your screen there. The PowerPoint, which we’ll go through slowly over the next half hour or so, is available for review, and any other materials as well. And you’ll see some bios also.

We will take questions at the end of the webinar, but as always, I invite you to ask your questions when you think of them—so we know they’re coming, and we know how many there are, and we can figure out who’s going to take them. So, keep firing away the questions as soon as you have them, and we’ll make sure we answer them. If we’re unable to, if we run out of time, and unable to get to all of the questions, which is always a good problem for us to have, Arena will get back to you directly. We do know who’s asking questions, so it’s a good opportunity. Or if you want to ask a question and have it addressed offline, that’s something you can do as well. But be liberal with the questions. Fire away.

If you’re watching this on demand, you can still ask questions. So, if you weren’t able to make this live, but you have downloaded, we still care very much about you. We want to make sure your questions are answered, and they’ll go to Arena. So, make sure you ask questions, even if you’re watching this at your convenience, and I bury the leave, but yes, this webinar is available on demand. So, if someone who would benefit from this, but they were unable to make this time live, let them know they can go to devicetalks.com to register.

A few quick things about DeviceTalks—there are all of our podcasts. We’ve launched a couple since we’ve seen you last, so that we’re up to nine, and you can find all of those at devicetalks.com and also any podcast player. And we’ve got a few more coming, so we are going to need a bigger slide. And we will be meeting in person on May 1st and 2nd at DeviceTalks Boston. Registration for that is open. If you’d like more information about that, go to Boston.devicetalks.com. Or if you just want to go to devicetalks.com, you can find a link pretty easily. But as I said, registration is open. We’ll have great presentations from a lot of the leading OEMs, and a lot of great partners, so please do check it out.

All right, let’s get into the business at hand. Once again, very happy to have Arena as our first sponsor of 2024, and I’m going to introduce our panelists. You already have their bios as I mentioned, but this conversation will be led by Scott Segrin, Solution Architect at Arena, and Gay Groce. She’s Customer Success Coach at Arena. Again, questions, questions, questions, questions, question, questions, fire away when they come to mind, but for now I’m going to, well, first I’ll just let, in the middle we’ll have a poll question for you, so prepare yourself for that.

But at this moment in time, I’d like to hand the presentation over to Scott Segrin, again, Solution Architect at Arena. Scott, you able to take it away?

Scott Segrin

Hi, everyone. Again, my name is Scott, and glad to meet everybody that is in attendance today. And again, we’re going through a deep dive into the QMS compliance for medical device. We have a quick agenda, and the agenda is a QMS overview.

What challenges, and requirements of QMS, and the benefits of using the product-centric QMS system? So, what is QMS? It’s a quality management system. Usually it’s a formalized system that documents all your processes, your procedures, your responsibilities for achieving quality policies, and objectives. This purpose of this is to ensure that every time that a process is performed, the same information, the methods, the skills, and the controls of those are used and applied in a consistent manner.

If there are process issues, or opportunities, this is then fed into the quality management system to ensure a continuous improvement of your processes. The benefits that you get from quality management—it will strengthen your competitive position, the adaptability to changing and emergency marketing conditions into environmental and other government regulations.

This was so key from a couple years ago with COVID that all the market conditions changed. And having a electronic PLM system that’s connected to your product record, and also to your QMS together in one system, was quite the advantage of those companies. Higher productivity, enhanced market image. It’s the elimination of defects, and waste, and the reduction costs, and better cost management. Of course, all of that means that you’ll have higher profitability, and approved customer focus, and satisfaction that they will get from your product.

In quality management system regulations, there are many out there like ISO 9000, but in medical device specific, we have 13485, the 21 CFR 820, the MDR European submission process, and of course FDA submittal process for when you’re trying to get your products approved, and all following these medical device specific standards, and regulations, or products either sold in Europe, or U.S., or other countries around the world.

Gay, you can take over.

Gay Groce

Welcome, everybody. I’d like to speak a little bit about some of the challenges and requirements that companies face in maintaining a quality management system. We’re going to talk a little bit about how do you work today?

How do you manage that product quality today? How do you communicate within your own teams, across teams, across sites, with your supply chain, which is very critical today. What is working, and what is not working?

You have data issues, you’ve got lots of errors, silos where you have multiple systems not connected together. Bottlenecks, people not responding to different change orders, or getting their documents released so that you’re not staying on top of your quality initiatives, and delays, constant delays in getting things done. So, you’re missing time to market.

We are going to do a little poll right now. Tom, do you want to go through the questions?

Tom Salemi

I do, I do. So, yes. So, the question is how do you currently manage product, and quality? Please select the option that best represents your organization’s approach. So, your choices are manual processes, so paper-based workflows; basic digital tools, spreadsheets. C is QMS; D is custom solution; and E is none of the above. So, those are the choices you have. Take a moment to consider how you currently manage your processes.

And I failed to mention at the top that if you’d like to look at future episodes of DeviceTalks Tuesdays, just click on that logo up top. We added that button for you, and that’ll get you to the registration page.

But, so you see the answers are coming in, I would like to get as many answers as possible. Thank you to everyone who is voting. So, once again, manual process is A; basic digital tools B; QMS C; custom solution D; or E, none of the above. So, still coming in. Thank you everyone for voting. It’s great to have an energetic group back here for DeviceTalks Tuesdays.

Someone’s honking a horn outside my window, which is very much appreciated. All right, I think we’ve seen the trickle of, the flow is now a trickle, and I think it’s stopped.

All right, I think we can move on to the next. Did I…

Gay Groce

Oops.

Tom Salemi

There we go. I’m sorry. That was me. That was me. We have a new interface. There’s buttons everywhere, people, we’re trying to figure this out, but here we go. Here are the answers for you, Gay, to review.

Gay Groce

Okay, manual process, 8.6%. Basic digital spreadsheet, tools, excuse me, spreadsheets [9%]. Wow, QMS. That’s awesome to see. 74. Custom solutions [6%], and none of the above [3%]. Well, maybe with none of the above, maybe we can address some of your requirements here.

So, does this kind of look familiar, this process here? Some common symptoms of a disconnect between approved product, and product field where you have engineering referencing in your CAD system. And then recurring quality events happen while they’re trying to design the product. Quality events don’t reference the correct product versions, or parts. So, manual error, prone synchronization, error efforts, and the lack of collaboration between, and a lot of team finger-pointing.

So, you have these different teams, they’re all working in silos, and not communicating, so you don’t have your right approvals. The FDA is not going to be, the requirements are not going to be met. You’re having constant design changes, and the quality team is trying to make it all seamlessly work together. So, working with the thousands of products that product companies, we’ve seen a common, indeed universal challenge.

A lot of disconnection across people, data, and systems as they work to put all this effort and innovation into a product. You might find this one familiar. It is surprising that as companies grow, their teams work on the product from ideas to launch. They cobble together various point solutions, drives, or cloud shares, document management systems, and other tools to track information as specific needs arise. This continues as the company grows—more people, more data, more systems, a patchwork of the data silos, and collaboration deserts. Some of the disconnects are the people, the responsibility can’t find the right information. They have a lot of tribal knowledge within their team. Data. Data disconnected in silos, poor integrations not accessible to all teams.

Accountability, traceability, a lost IP, change cycle times have grown, and product is built to the wrong version, designed to wrong requirements, poor design quality, and now you have increased cost, reduced profits, dissatisfied customers, more noncompliance.

And now you’ve lost market share. Scott, you want to take over?

Scott Segrin

So, what’s the benefits of using Arena platform for PLM and QMS? So, Arena QMS—the QMS is for the data, the documents, and all the processes: your SOPs, your work instructions, all inside this one system. It supports your FDA regulatory compliance either to 13485, or to 820. It’s a business-ready application. It’s cloud SaaS. Everyone has the same system.

What’s really, really important is Arena has not only a QMS, but it’s also a PLM system. So, your product is also in the same system, which now allows you to connect all your QMS process, and reference link to your actual product, which now will also give you trend data right on the particular item and go to any of the quality processes that might be on that item.

We also have supplier collaboration. So, we have suppliers that will be able to access directly to an Arena, and we also have Arena Exchange, which can export from Arena to Arena Exchange. And you can give certain individuals outside of Arena access to whatever data that you would like, and communicate. So, internally, supply chain can be part of the processes, and externally there are ways to communicate through Exchange, but it’s important that everything is in one system.

So, your document management system. So this is, of course, all your procedures, change management of that, whether it be change controls, or change orders, or even deviations, all within the system.

You have your supplier quality management. You are managing your suppliers, that is your vendors, and/or manufacturers, right off the components, and items inside of Arena, product data, you’ll have your supplier information, and you’ll manage both the supplier and the sourcing of those parts.

You also have project management. So, in project management you can create project plans. Very easily, very user-friendly to manage new product introduction, as an example. We have analytics section that will, you can create real-time analytics that as each change order is done, or each quality processes process, it’s real time using a data warehouse that will give you those on-time analytics, supply chain collaboration, as I mentioned, configuration management on your bill of material.

How do you process your changes in your bill of material, how do you remove parts, how do you add parts? All of that configuration management is controlled in there. We have built-in training management that is connected to your SOPs, or work instructions, and it’s real time so you don’t have to manage it from a desk with a piece of paper, having people read it, and sign off on a piece of paper.

Anytime a document changes that’s on a training plan, automatic notifications go out to the individuals that they have to train, and of course quality management, which ties it all together. So, these could be your CAPAs, your complaints, your nonconformance, your audits, your management reviews, your design history files, your device master records, clinical data. All of it’s managed through the quality management process. And it’s also, again, connected directly to your product records. So, if your item number, or your assembly number, then you can get to all of the information that’s linked to it, very important, and why it eliminates all the silos that you may have with different systems having it all in one.

The Arena QMS will expedite your regulatory compliance. FDA, and notified bodies seek to confirm three major elements inside of an electronic record, and electronic signature systems. One is an audit trail, right? You got to have an audit trail. That audit trail has to have all your prior revisions. So, we have change control processes built in, connected to each one of the items.

The document history, there’s a history tab on every item in Arena, not only to the change order, but the complete history of that item, and sign-off information with electronic signatures, both in change orders, change requests, quality processes. All of these are all electronic signatures that are connected to each one of the processes. Second portion of this is security, authentication based upon the unique ID, and password.

So, we can connect to single sign-on systems if you have them, but inside of Arena you’re going to have an Arena ID, and you’re also going to have an Arena password. Each time that you do a task inside of any one of the worlds in Arena, you have to use this unique ID, and you have to use your unique password that’s an Arena. It’s encrypted, encryption. Modern methodologies include the SSL. Passwords, automatic password, aging, so you can set up the aging of your password for when you want to have a password reset the number of months.

Authorization based on predefined roles. We have access policies that you can manage and control, that will allow certain groups to see certain things, or do certain things in there by using access policies. Change-control actions require the electronic signature for any sign-off information.

Validation is the third in most major element, and software must be validated, and maintained in a valid state CFR 20, or 13485. We provide what’s called Arena validate as part of a purchase. That’s the IQ and OQ information of Arena. It is done with every single version change of Arena and given to anyone that purchased Arena validate will have this information right at their fingertips, and be able to access, and/or download that information. We also now provide PQ templates for your internal processes that you may have created, and need to do a PQ. We give you templates that you can easily modify to what your current processes that you have created. Unique user configurations, and load network, and additional requirements that are not covered by the validate package, which is that PQ.

QMS facility requirements. Again, complaint, these are the key QMS facility requirements that the FDA and 13485 are looking for complaints. You need to clearly identify complaint risk factors, owner responsibilities and procedures. You need to review, evaluate, and investigate possible device labeling, and/or packaging failures. Provide access to manufacturer establishments when designated client unit is remote, domestic, or international.

We provide, in our package, templates—quality templates that can be easily modifiable to however you want to make up a complaint form in the QMS. It’s very easy, user-friendly, easy to modify, and create a template that can be utilized for every complaint process. Same for CAPA, and CAPA below is of course identifying the causes of quality problems to investigate the cause, nonconformance, and identify corrective and preventive action. Verify and validate the corrective and preventive action, and implement and record the change, and disseminate information to those directly responsible to notify for management.

So, not only can you reference link to the product, you can reference link directly to another quality process. So, they’re all connected together in Arena. So, it may start off as a complaint, which then might get created as a nonconformance. And then that nonconformance can be reference linked to a CAPA. And that CAPA may require a design change, which means that you can reference link it to your design history file, and/or the change order process.

So, they’re all linked together, so you can click on the product, and you can get to these quality processes that were created, or even directly to your design history file where those will also be done. And of course, training—you’re going to have all these SOPs and work instructions that are explained, all of your quality management systems, everyone has to be trained to those. And so you have to establish and document procedures for identifying all your training needs. Ensure that all personnel are adequately trained, and you need to make personnel aware of device, or defects due to improper job performance, and make the verification and validation personnel aware of the possible defects and errors that were encountered as part of these job functions.

So, we have a training world, again that’s referenced linked to the product and/or procedures. So, you’re building up trend data off of all of those. The training plans will also set off automatic training notifications in the training world. We do have quizzes that can be easily built onto each one of those procedures to know that people have read, and understood, and material… With electronic sign-offs that they read, and understood the material and/or passed the quiz, so Arena can support these facility requirements.

One last one here is just showing you that what Arena gives you is a single source of the whole product truth from revision control to your product, to quality analytics to regulatory, and environmental compliances, quality training, CAPA records, requirements, and issues in supplier management.

All connected into one silo for one single source of the truth. Gay, take it over.

Gay Groce

So, Scott mentioned quality supplier qualification, and management. So, we have licensing available that allows our suppliers, our contract manufacturers, our partners, design partners to come into Arena, and collaborate with your internal customer teams.

Supply chain partners have different needs, so they might just need a specification. They can gather pertinent, like your contract manufacturers can certainly gather the bills, and materials, the latest sourcing for the items, and who they need to buy from to build your product. Sharing information with other various members within their organization as well. And with multiple supply chain members that you’ve approved through the quality process, actually you can use the quality world to do supplier approval, and to help manage your AML.

Gathering the input from one version of the product to another. So, as changes come through, the supplier has access to that information, they can improve change orders, they can approve and monitor quality processes, and be involved in the different DHF changes that you might have to adhere to. Arena supplier license enables this, and it’s set up. And for design partners, you can have it as a partner, you can have it as contract manufacturer, and just off-the-shelf suppliers as well, if that’s what you would like to do.

The supply chain collaboration, again, it allows you to bring in design partners, contract manufacturers, suppliers. You can connect all kinds of external partners to speed the delivery of the products. It has a platform designed for secure rapid collaboration, and traceability from early design through the volume production. You can use a formal real-time collaboration, and informal discussion options.

Teams benefit from a layered security to protect your critical intellectual property just because a customer, or a supplier has a license, you have control over what they can see, what they have access to, but at the same time, their ability to take advantage of engineering changes, and design reviews, or quality issues, this access gives them all that capability. And then our quality processes actually allow you to do approved manufacturing processes, or vendor-approved vendor processing so that you always maintain an accurate and reliable AML, or AVL, to use for your production.

And again, goes back to the access policies that Scott talked about earlier. You can set up specific access policies for these suppliers, and certain roles so that they only can deal with the information that is pertinent to them. Scott also mentioned briefly about Arena Exchange. This is an option in case you would not want to bring your suppliers directly, or partners directly, into Arena. Arena has the capability to export PDX files, which can include all the items within a product, all the BOM structures within a product, all the files within a product, all the sourcing information, all the, and export that into one single PDX package.

And then the people that need to see these packages have a link that they can register on, and it gives them access to download that information, and then they can see the product structure. They can see by item number, or by top-level number, all the different sourcing information. They can see by item number, the files that are attached to those. And there is also a collaboration tool built into Exchange where you can share information, vote on changes, approve changes.

And so it gives you a good collaboration tool built right into Arena Exchange. And no licenses are needed for this. It’s free. They don’t have access like I mentioned to Arena Workspace, but it’s easily compiled in one package. You can also export not only product structures, but change orders as well, and send them out for them to review. And with the collaboration tool, they could come in and approve those changes, share information with contacts after granting them direct access to your workspace if you want to.

And then like I said, participants can review, and collaborate directly around one version of the build package. And within the collaboration tool it also records all the comments. So, any comments, or issues, or approvals that take place within Arena Exchange are recorded for that specific package that was reviewed with the team.

Okay, Scott?

Scott Segrin

Arena quality management. So, I mentioned earlier about quality templates. So, we have these out of the box that are supplied directly to each customer. We will walk through these templates, explain the templates, show you how to modify these templates, and show you how to create new templates that can be used in your quality management system. This is anywhere from audit forms to inspection records to complaints, corrective action, design history file. We have an MDR technical file for submittal to Europe, a 510 submittal checklist. And we also have more. We’re building the library as customers allow us to copy their templates that they create. We’re building a library, and if you’re looking for something, we can actually supply you a starting point for it. You’ll read it, you’ll modify it, and make it for what your needs are very quickly. Very user-friendly, very easy to do. So, one of the major things, of course, with any FDA, or 13845 is being able to perform these internal audits.

You’re going to have to do external audits for sure to govern bodies, and to FDA, but internally you’re going to have these kind of different kinds of audits that you’ll need to perform. And having a tool inside the system to be able to manage these, and be able to reference link to SOP, or work instructions, and build trend data on each one of these to help the engineers and/or facilities, and/or any organization within your building from supplier audits, production team audits, safety audits, facility, environmental, risk assessment, configuration management audits. All of these are possible internal audits that you’ll perform. And these can be managed and controlled within inside of a quality template, inside the quality management world.

I’ve mentioned a few times, you have the visibility within the product record. Controlled access to your product information throughout the whole life cycle of your product. From prototype all the way to end of life, a bill of material, what’s the out of back, and custom views, the out of the box, and custom views of a bill of material. Fully indented bill of material, or custom BOM that you would like to create. Arena will automatically give you flat BOMs out of it. Also, that can be then integration to an ERP system.

We also connect to your MCAD or ECAD systems directly through third parties, but we have a lot of customers that do that, so it’s easy to push data in, push data out. We have API functionalities that can also do that, and third parties already have integrations created that we will recommend. Revisions, dynamic change control of various stages of your bot. We have a design stage, we have a production stage, a non- lease stage, a design stage, and a production stage. You can set up your configuration on those the way that you would like to have them, based upon the forms and/or lifecycle of your particular items.

As Gay mentioned, we have a proof-of-vendor list, sourcing on the parts. You can even have costing on those. So, you can have a costed bill of material. That can be, if you have an integration to an ERP, that data can be pushed back. Costing data can be pushed back directly into Arena to update the cost automatically. So, you always have an up-to-date cost to bill of material. Compliance requirements are directly attached to the components. So, there’s a quality tab on every item in Arena. Any quality created will be referenced, linked to that item. And now on that quality tab, you’ll see all the customer complaints, all the CAPAs.

So, you’re building your trend data. So, when you open the item, you can see any common issues that are happening, and get those corrected as quickly, and faster than possible when you have it. Quality events directly linked to certain versions and/or items. So, you can do your reference link to specific revisions instead of latest and greatest. You can go and put a nonconformance to a specific revision of the item. Called in… You have a trend data, as I mentioned, collected directly onto the item. Product requirements are directly related to the design control. So, we have a requirements world that you can create all of your product requirements, like user requirements, or system requirements, and those can be all tied through your design control process by creating the requirement and requirements world.

And then for your design inputs, and then for design outputs, you can have all of the items released under items, and reference link back to your requirements world.

So, what does all this do for you? Of course you can now scale, and you can grow because you have a system that controls all your data. It has dynamic workflows, integrations, access to all your data. It has business insights. It’ll uncover your gaps, your opportunities in product processes with Arena analytics by good data. So, we have a data warehouse that’s connected that gives you real-time analytics, and gives you those business insights that will help you improve your processes, and your product, and supplier manage, increase process efficiency, ensure data accuracy, and sharing, collaborate on product information.

So, performance validation, I mentioned it a little earlier, but again, FDA requirement here is listed above on what we need to do. How do we meet this requirement for you? We can provide you the IQ OQ of the system. Remember, this is a SaaS system, totally Cloud. Everyone uses the same software. You don’t need hardware, you don’t need software.

What you need is just an annual subscription to come into our software. We also will perform the IQ OQ, and you can have access to that data at any time. We give you the PQ information templates, because customers should establish their intended uses, and determine what additional efforts are needed to validate your customization that you have… configuration changes that you have made. Excuse me. So, Arena gives you PQ templates to assist customers in fulfilling. We also have a third party that these documents belong to that can actually perform the PQ for you, and fill out and create all your documentation you need.

Arena can connect to customers with industry experts should any additional assistance need to be acquired, like that third party that we have. Gay?

Gay Groce

So, just to give you a little background, here are some of our customer stories.

Potrero, who also is one of my customers that I represent and help. Some of the challenges they had were meeting audit goals due to manual product development processes. They needed to ensure compliance with ISO, FDA, and EU regulations for commercialization. And with the implementation of Arena, and putting in their configuration, their business processes, they had the ability to scale product development and auditing processes.

They eliminated IT infrastructure investment because like Scott said, this is a total of SaaS cloud product. All you need is a subscription and access to the internet, and you can have access to Arena. And because we do the validation, the IQ, and the OQ, it ensured compliance validation. And a quote from Sanjay, “Arena QMS is a true lifecycle management system that is better than the typical document-focused QMS solutions. Being able to manage BOMs and changes along with quality processes is a major advantage.”

So, based on their implementation of Arena, they had a 98% success in training compliance. They had 30% shorter ECO cycle times, they had 25% improvement in ECO quality, 25% decrease in complaint cycle time, and a 20% improvement in component nonconformance. So, you can actually see the results of using a total QMS system such as Arena.

A couple more. Swan Valley Medical. Swan Valley Medical is a single-use urology instruments adopted Arena in 2011. They faced some challenges with inefficient paper-based quality management processes that also created some compliance risk issues. An FDA regulated company, they needed to maintain a system and detailed records to support operations, and exceptional quality standards. Arena QMS allowed Swan Valley to eliminate multiple siloed systems for document control, and centralized information for a single source of product and quality records, and also reduce compliance audit risks.

Another customer: Pulse Bioscience. Pulse is a novel bioelectric company that adopted Arena in 2016. When they implemented Arena, their challenge was to ensure the entire team used closed-loop processes for rapid, continuous improvement as they went through R&D phases, and they had a must-have training compliance requirement. Arena provides that single source of product quality, and training management. At Pulse, everyone uses Arena—from the CEO to quality specialists and engineers.

And last but not least: IntraOp. It’s a portable radiation device. It also adopted Arena in 2016, 10 years after the company had already been in business, and IntraOps mobile radiation devices transformed cancer treatment care for patients. And now the company is working on another innovation, noninvasive treatments for skin cancer. IntraOps’ need that brought them to Arena is the biggest barrier to innovation: the ability to effectively track quality matrix for meaningful insights that power decisions. Using Arena, not only did they solve the same challenges Swan Valley and Pulse had, but they now monitor quality performance daily to optimize for continuous improvement in everything they do.

These are just a few of our logos, very few of our logos that are part of our life science family that have implemented. Some of these have been in business for many, many years with Arena. BioFire, I think I was looking… They’re one of my customers as well. I think they’ve been Arena customers since 2003. So, a lot of these have been in here for at least more than 10 years, some of them.

If you want to learn more about Arena, this link to our website will get you to a salesperson that you can talk to about subscription costs and that sort of thing. There’s also several demos on the website that talk about the different uses of Arena, and shows you the different worlds within Arena, as we call them. There’s also a section on the Marketplace that shows you about our partners that we do, because we do a lot of integrations with a lot of ERP companies, CAD design companies. And as Scott mentioned, we have customers that are partners that help with the PQ, and quality management systems. So, there’s a lot of really good information on our website that can get you going. And as you can see, we’re a leader in the PLM business.

Watching on demand, still list your questions. We do have a couple of questions, Tom?

Tom Salemi

Yeah, I’ve got some questions here from the audience, and folks, there’s still time. We’ve got about a little over 10 minutes to get your questions in, and we can get started with a question from Michael. The question is, what is the impact, how much remediation is needed of the new FDA new ruling for QSR in the harmonization with ISO 13485? Thanks for getting me started, Michael, with a lot of numbers in there. So, what’s the impact? How much remediation is needed of the FDA’s new ruling for QSR, and the harmonization with ISO 13485?

Scott Segrin

So, you are going to have to revamp your quality process. So, the exact details on what you need to do, we’re a software company, we will support that, but we do have an MDR quality template that is 13485 that is used in the EU. It goes into the exact details of what is required for submittals, but the terminology is different. Processes are different. So, again, we’re a database software company.

What the exact differences between the two? You’ll have to go to the experts on that, but we can help support that. And we do that with presently 13485 with EU.

Tom Salemi

Okay. Next question we have from Zachary: Is Arena part of the PTC Windchill family, and does it require Windchill to function?

Gay Groce

PTC and Windchill are different. We’re all part of PTC first of all, but Windchill is a separate division from Arena, and you do not need Windchill to function with Arena, though.

Tom Salemi

Okay, great. And another question here. How does Arena connect with existing tools and systems that companies may already have in place?

Scott Segrin

So, we integrate with many different types of software from ECAD to MCAD to anything, because we have APIs that can pull the data from Arena to any kind of software that you would like using those APIs. But we have third parties that also do the integrations that have integrations already built for the major MCAD, ECADs, and ERP systems that we have as partners that we can also give to you.

Gay Groce

Also, just in addition to that, we also have our own CAD. There’s a new SaaS, well, it’s not new, it’s been around for a while, SaaS Onshape, which is a mechanical CAD system that integrates seamlessly to Arena, and it’s in the Cloud. Again, there’s no hardware needed, or software. It’s totally based on your browser, and that’s available as well.

Tom Salemi

Okay, next question. And we’ve got a couple around the same sort of theme, but for companies without a dedicated regulatory affairs team, how user-friendly is an Arena for non-experts in regulatory compliance? And do you folks provide any kind of training for customers?

Scott Segrin

So, we do have online training every month that folks can sign up for. For sure, that’s part of their contract. With every new integration, the solutions architects, we’ll do workshops on each one of the worlds, and help them setting up their templates that they need. We provide templates for them. We also provide an out-of-the-box workspace that can be used for this type of company, and jump right into it. And we have, again, quality templates that can be just, without changing, you can utilize them for what you like.

So, it’s very easy to use, very user-friendly, and we make sure that we do that training. After the workshops, it then gets turned over to a coach—that’s Gay. And Gay is always there to support you, and always give you best practice, and help you with anything you need. So, you always have a point of contact that Arena will help you.

Tom Salemi

All right. And similar question: What are the hardware/software requirements of your system? And the larger question is, so are you, and we get this question a lot from folks, is this something that a startup could use a couple of people? Is it built more for larger companies? Are you able to scale bigger, and smaller? I think you’ve got into that a bit in your presentation, but if you could just sort of reinforce that point. So, what are the requirements, and are you able to work with companies of many sizes?

Scott Segrin

So, there is no hardware.

Tom Salemi

Gay, we want to go with that one, and then… Gay, go first, and then we’ll go to Scott.

Gay Groce

I’m sorry. Yeah, no, you don’t need any hardware, or software. Like I said, you need access to the internet. It’s just browser specific, and a paid subscription, obviously, to get into Arena. What was the second half of that question?

Tom Salemi

Was more curious as the size of your customers. Yeah, yeah. Companies…

Gay Groce

We have customers. Yeah, I have a customer that has nine employees, and I have customers that have 2,000 employees. So, it goes all over the map. However, there is no restriction at all how big your company is.

Tom Salemi

Okay, great.

Gay Groce

Scott, you got anything since you do a lot of the implementation?

Scott Segrin

Well, we can have customers … we’re small to medium … we can have customers that have two licenses all the way up to hundreds and hundreds of licensing. Not an issue for either one.

Tom Salemi

And do companies internally, do they tend to need a level of professional to work with you? We mentioned before about if a company has, or doesn’t have a regulatory team, do you deal with laypeople who have no regulatory experience at all, but they’re more software people? Who is the point of contact that needs to be in the company that’s a customer of yours? What level of skillset do they need?

Scott Segrin

So, we’re a database company, and we’re going to provide you templates to meet the requirements, but that’s the company’s decision on how they’re going to manage their product and their systems in a regulatory environment. We will help them and give them best practices. It needs to be their decision on how they do that. So, they may need to have a contractor that would work with us and create those processes for them, but we’ll be more than happy to give best practices.

Tom Salemi

Sure. Gay. Anything to add to that?

Gay Groce

No, no. It’s just good to have a good understanding, if just an outline of, like Scott mentioned, how you want to manage your change control process, how you want to do your item numbering. Those are just some basic features that Scott would start out with when he’s implementing a new customer.

So, just some of those basic things, and then you can grow over time as you mature as a company and bring in more. You don’t have to do it all at once. You just do the basics, get your documents, then maybe your BOMs, and start thinking about sourcing so you can do it on steps rather than trying to do it all at one time.

Tom Salemi

All right, great. I think that’ll be our final question. It’s a great way to start the season. Gay and Scott, thanks for joining us, and for being on DeviceTalks Tuesdays. We appreciate the presentation.

Scott Segrin

Thank you. It was our pleasure.

Gay Groce

You’re welcome. Thank you very much for having us.

Tom Salemi

Great. Thank you all, of course, for returning back to DeviceTalks Tuesdays. It’s great to have you here. As I said, we’ve got a full schedule of episodes coming up. You can look at devicetalks.com, or click the little DeviceTalks Tuesdays button on your interface there, and see what’s coming up.

But once again, this is a great way to start, and very happy to have you as part of DeviceTalks Tuesday. Thanks for joining us, and have a great evening, or afternoon.