Learn about best business practices for product realization processes
The defense and aerospace market beckons to many product companies seeking to diversify, but also demands regulatory compliance in addition to the quality, product development efficiency, and technological innovations every market needs. Many product design and manufacturing companies in this market provide products subject to export regulations, including International Traffic in Arms Regulations (ITAR) and Export Administration Regulations (EAR), requiring compliance in technical data handling and access.
Medical device companies must overcome many hurdles to get safe, high-quality products to market. While their primary objective—creating safe, innovative, and valuable health solutions—is challenging enough, medical device companies must also navigate a myriad of regulatory compliance issues before products can be sold to doctors, hospitals, and patients. Establishing and maintaining an effective quality management system (QMS) to satisfy both the FDA and ISO is critical. And, when the system is software-based, then the manufacturer must also demonstrate and provide evidence, or validate that it meets the requirements to consistently deliver safe, high-quality devices to market. Read this white paper to see how Cloud QMS simplifies software validation.
Achieving and maintaining regulatory compliance is an imposing hurdle for many medical device manufacturers. Missteps and inefficiencies addressing FDA, ISO, and other regulatory directives can result in costly delays, warning letters, and even business closure. Today’s manufacturers must establish proper design controls to demonstrate devices are safe and effective for their intended uses. This requires a more connected approach to introduce new products to market. Read this white paper to see how product-centric QMS enables better design controls.
For medical device companies, having a rock-solid approach to quality is a prerequisite for success and innovation. The burden on quality and operations leaders to introduce compliant and innovative medical devices to market is great. And as regulatory standards, market requirements, and device complexities have evolved, so too has the weight of the burdens these leaders face.
New product development (NPD) and new product introduction (NPI) practices have shifted drastically over the last decade as companies have picked up the pace of innovation to survive and prosper in the face of customer demands for greater performance at a lower price, increased global competition, and more stringent regulatory requirements. Read this white paper to learn how to streamline your product development and launch processes.
Companies working with distributed teams and supply chain partners need to collaborate on the latest bill of materials (BOM) to reduce production errors and shipping delays. Learn how Arena’s Product Realization Platform provides a more intelligent and comprehensive way to control, share, and release accurate BOMs and related product information.
FDA regulated companies must establish quality systems for compliance. Arena’s product-centric approach enables medical device companies of all sizes to optimize quality management in the context of managing the entire product record.
Arena understands the huge responsibility of managing a globally dispersed supply chain team in an increasingly competitive market. Operations managers are expected do it all: select contractors, approve vendor lists, evaluate proposals and ramp product delivery. Learn their success stories.
This white paper provides an overview of manufacturing tools like mechanical computer aided design (MCAD), product data management (PDM), electronic design automation (EDA) and enterprise resource planning (ERP) and describes how to bridge the gap between engineering and manufacturing.
Manual processes including paper, spreadsheets, and email are often used during NPD and NPI. These tools can wreak havoc when product information is released into production. Read this white paper to learn how to accelerate ECO cycle time.
The ability to proactively monitor errors and predict failures with enterprise-wide visibility is critical. In this quality white paper, Arena highlights the pertinent best practices and benefits of managing quality to build a culture of collaboration and innovation.
As manufacturers shift sourcing decisions to their supply chain partners, procurement teams need to adapt with new tools to better control costs, manage multiple supplier partners and reduce supply chain risks. Discover the powerful benefits of PLM-based procurement solutions.
Medical device manufacturers must get their products while facing new technological challenges, global competition, and increased regulations. Read this white paper to learn the best way to navigate compliance with a single system of truth for all product and quality information available to internal teams and partners.
In CIMdata's analyst report, learn the important difference between a real and a fake PLM cloud solution. You'll discover the value of a true cloud multi-tenant PLM solution and its ability to provide all customers with continuous and instantaneous access to solution upgrades.
Today's innovative companies are built on the shoulders of the engineering teams responsible for designing products. A modern PLM solution removes tedious admin responsibilities, streamlines the design environment, and empowers engineers to collaborate more efficiently with other departments. See how Arena empowers engineers to spend more time on product design by optimizing their relationship with all teams.
The complexity of software validation has forced many medical device companies to forgo updates, upgrades, and/or bug fixes. Unfortunately, running outdated software curtails their success. With Arena, medical device companies can have the latest enterprise software with minimal validation effort and cost.
Companies betrayed by a fake cloud solution experience complicated and costly upgrades, downtime, unstable integrations, and security breaches. Learn how Arena’s multi-tenant architecture provides a real, scalable cloud solution.
Arena highlights best practices for and benefits of managing quality as an integrated part of your manufacturing business. We cover continuous improvement with quality process feedback throughout the product lifecycle.
Efficient product design and development processes are the key to success for every electronics manufacturer. Unfortunately, too many companies operate with a silos of data. We examine how an integrated cloud PLM system helps your product development teams have increase visibility across the complete product lifecycle.
Today's innovative companies are built on the shoulders of the engineering teams. Smart companies invest in solutions that help develop and deliver high-quality products to market fast. A modern PLM solution removes tedious administrative responsibilities, streamlines the development process, and empowers engineers to collaborate more efficiently. Read this white paper to learn how Arena helps move beyond early design.
Connected products are everywhere today. To put the "smart" in smart products, manufacturers need to manage the development of electrical and software designs more effectively. This Technology Spotlight examines the opportunity for manufacturers considering the deployment of PLM in a cloud architecture.
Quality Management Systems (QMS) and Product Lifecycle Management (PLM) both help companies speed NPD and NPI. However, in medical device companies, these solutions are often managed by different teams with limited, if any, connectivity between the systems. This eBook provides insights from Arena customers who benefitted having a single place to manage product and quality information.
From securing the best pricing to creating a strategy that works for each of your product lines, companies that outsource their manufacturing face a myriad of challenges. Through years of working with original equipment manufacturers (OEMs) and contract manufacturers (CMs), Arena has identified trends and best practices in this eBook. With the tips and advice in this eBook, OEMs will be better equipped for long-term success.
What solution helped a lighting manufacturer reduce engineering change order (ECO) cycle times by 75%, a networking company improve ECO cycle times by 70%, and a digital processing business accelerate time to market by 20%? The Answer: Arena's cloud-based Product Lifecycle Management software. Learn how Arena helped achieve these results.
Cloud manufacturing is bringing new competition to traditionally stable markets. Connected data is providing easy access to a global supply chain while driving down the cost of going from concept to shipping product In this white paper, you'll learn how Cloud PLM is streamlining product development processes.
New advancements in battery technology are an example of a disruptive technology impacting product design in the dynamic consumer electronics sector. On kickstarter.com alone there are an endless number of new gadgets made possible because of radical battery innovations. In this white paper, you'll uncover these secrets about battery technology and why some OEMs are better positioned to innovate.
The solution to clean tech's history of stuttered starts and stops may depend upon advancements in an unsung hero: the lithium battery. In this white paper, you'll discover how advances in lithium could re-energize the clean tech industry. You’ll also discover why Sunlink and other battery manufacturers rely on Arena to get their products to market on time and budget.
IDC Health Insights conducted in-depth interviews of users of a variety of PLM solutions within the life sciences industry. This case study provides examples of how life sciences companies are using Arena to improve efficiency, innovation, and quality.
New advancements in storage technologies are ushering in an era of rebirth and unlimited possibilities in renewable energy. In this white paper, we peer into the future of cleantech providing revenue projections and analysis of technologies that will shape the industry.