Few complex processes require more scrupulous attention to detail than taking a product from concept to design, through development and into manufacturing. And when it comes to medical device design and manufacturing, nothing is more critical than quality and compliance.
For more than 30 years, Fortune 500 companies have turned to Plexus engineers to design, develop and test healthcare and life sciences products. Plexus is ISO 13485 and Quality System Regulation compliant with engineering teams and manufacturing facilities around the world.
In order to ensure regulatory approval, Plexus needs to be able to guarantee traceability and documentation. After considering a variety of solutions for a collaborative, compliance – and audit-friendly requirements management tool, the team selected Jama.“Our main performance measurement is the repeat business we receive from our customers. They don’t come back if we’re not meeting the schedule and project budget. And these are things that Jama helps us do,” says Dave Strandberg, Director of Engineering Solutions.
Since introducing Jama, Plexus’ distributed teams are able to more efficiently collaborate on the requirements of their Class II and III medical devices. With Jama, Plexus has dramatically reduced the time it takes to assemble test data and shortened time to market.
Learn more about how Jama is helping Plexus deliver to their customers again and again with the confidence of proven compliance. Read the case study.