Breakthrough Insights

Achieving Traceability for Regulated Medical Devices



As the technology that we use in our everyday lives has become more connected and complex, so have the medical devices that people around the world rely on to improve or even sustain their lives. The margins for error are razor thin and the need for continuous improvement is non-negotiable. The need to innovate is ever present and so is compliance to regulatory standards. Recent announcements from major companies like GE to invest in medical device startups suggest a broader trend toward acquisitions and mergers in the industry, which has faced venture funding challenges in the past.

With all of these changes happening at once, it’s more important than ever to ensure that engineering is aligned with the business and people and data are connected. Over the years, Jama has served large and small medical technology companies alike (see a select group of our health care and medical device customers here). Plexus, which provides product development, manufacturing and aftermarket services, became a Jama customer while looking for a way to improve their product development process. The company needed to provide improved documentation to the FDA in order to maintain compliance. They needed to understand the impact any change would have on the product, ensure compliance while boosting efficiency, and knew Jama could help. By bringing Jama onboard, they were able to achieve their audit goals and continue developing with confidence.
Next week, Jama’s Jess Stetson and Plexus’ Jason Buttron will discuss the challenges of traceability for medical device makers and how they’re overcoming this problem. Reserve your seat now and join us on May 24.