While our new Arena Quality module is yet one more example of why we continue to be the de facto standard for OEMs searching for a medical device PLM solution, we keep reading guidance that a blog shouldn’t be too ‘salesy’ and it actually has to provide thought leadership to get read. Gasp.
If you’ll indulge me with my ‘parsley’ opening (to get my leader off my back) I promise to finish with six strong hunks of red meat that’ll add a smile to anyone wanting to learn about the mainstay issues confronting medical device OEMs today. The parsley: Arena Quality will benefit any company that values quality feedback earlier in their product development process. Ergo manifesting in getting a better product to market, with a smoother and faster overall NPI process. Arena is not new to quality, as we’ve been offering guidance in this area for over a decade; however we’ve made strides of consequence in this recent release. Okay. Now the meat: Here’s a breakdown of some of the top resources Arena has for medical device companies.
Getting an innovative, cost-effective product to market quickly requires collaborative interaction of all key stakeholders throughout the product design cycle. In this eBook, you will learn the best practices to ensure quality while using a medical device PLM solution.
One of the largest benefits of a medical device PLM solution is the ability to be prepared for an FDA audit. No running around looking for missing paperwork or digging through manila folders to find the document with the correct signature. This article will give you five great tips on passing your audit with my favorite being “show the auditor you do what you say.” Demonstrable, buttoned-down proof of your quality processes is one of the easiest ways to breeze through your audit.
This article provides a comprehensive overview of the traditional methods of document control and explains why they’ve become obsolete. Expecting your colored folders and spreadsheets to keep pace with the challenges of “compressed product lifecycles, stringent regulatory requirements, geographically dispersed project teams, cost pressures and outsourced partnerships” is hopeful at best—a fool’s folly at worst. Click the link above to learn why leveraging a cloud-based automated solution is one of the few ways you can take back control of your document control processes.
When its potential is fully realized, a medical device PLM solution is one of the best ways to improve the time, efficiency and quality of any new product development process (NPD). Once a company employs a medical device PLM system with 21 CFR Part 11 compliance capabilities, it’s best to organize and document implementation and standard operating procedures (SOPs) to get the most out of the system. This article gives you advice on how to make the transition from paper-based processes to digital as smooth as possible.
Argus Imaging has been an Arena customer since 2011 and it didn’t take them long to see the value in PLM. “During the introduction training for engineers, everyone quickly became clear that it is a great advantage when the information is centrally available,” explained their implementation partner. Since then Argus has witnessed the benefits of a PLM system through improved cost structure, collaboration with suppliers, reduction of ECO cycle times and BOM efficiency. Check out the case study to learn more about Argus and the richness extracted by implementing a medical device PLM solution.
If you’re the type of person who’s not interested in stories—rather just interested in facts—then I saved the best for last. Our Validation and Quality Management datasheets give OEMs information you need to know about how a medical device PLM solution can improve your current processes.
Thanks for reading and we hope these resources provide valuable insights. Have another piece of thought leadership you believe our readership would enjoy? Kindly share and comment on our blog.