At Flexan, you can find one of the most comprehensive accumulations of collective knowledge in the world of contract custom manufacturing for the medical device industry. Our compilation of whitepapers, publications, events and more is indicative of our positional excellence within our industry.
Getting a medical device cleared by the FDA is a challenging process. At Flexan, we’ve developed expertise over several decades of critical experience in ushering medical device components through the FDA submission process. In this article, we are going to...
When a company brings a new medical device to market, the road can be long and complex. There are several regulatory concerns to navigate. Additionally, there are some very important considerations regarding manufacturing. Manufacturing processes, assembly requirements, packaging and other...
When we talk about partnering with OEMs, we often reference the fact we have a very robust quality management system (QMS). It sounds great, but what does it mean for you and what does it mean for Flexan on a...
As an OEM, it is your responsibility to ensure the parts supplied to you are compliant with ISO regulations. That is no easy task. Ideally, your supplier’s quality systems are strong enough to identify risks, prevent defects, and to catch...