Sherry Dickson is a Senior Solution Consultant for Arena Solutions with 30 years of PLM, QMS, and ERP experience working in the medical device and high tech industries. Sherry has managed new product development and introduction processes, administration, and implementation within PLM and ERP. Sherry has a B.A. in Business Administration and Computer Information Systems.
Read more great stuff from Sherry below!
There are two main paths that medical device manufacturers
can use to bring moderate- and high-risk devices to market with the FDA’s
permission: through submittal of a premarket approval (PMA) request or 510(k)
PMA application is a more extensive approach, requiring substantial evidence
that provides “reasonable assurance that the device is safe and effective”
through methods like clinical trials, and results in FDA “approval ...