Regulatory
CMEDDS develops and executes regulatory strategies for medical device manufacturers. CMEDDS consultants provide support across the full spectrum of product design and development to post marketing compliance. Supportive documentation and clear organized execution of design activities is essential to successful clearance of a product.
Some of our past projects include managing surgical and interventional cardiovascular and orthopedic device trials. CE Clearance for Class II GI, General Surgery, Class III Cardiovascular and Neurovascular, and 510k Clearance for Cardiovascular and general surgical devices.
CMEDDS consultants work with each client to develop practical solutions, implement regulatory strategies, plan testing and prepare submissions. Whether it's guidance regarding product classification and predicate research, to preparation of a technical file; CMEDDS will provide the support necessary to gain product clearance.