Premarket Regulatory Strategy

Market Entry Strategy
Design Verification and Validation Testing Input and Oversight
510(k) / IDE / PMA
CE Marking / Technical File / Design Dossier Preparation
Combination Products
Medical Device Development Project Management
Clinical Studies
Canadian Medical Device Licensing
International Product Registrations

A well designed and executed testing plan can be the difference between a single cycle review and having to withdraw your premarket submission. Keystone Regulatory Services has the project management experience to ensure that your premarket development strategy, testing and submission integrate smoothly and provide the best opportunity for a single cycle review. Our approach emphasizes the importance of obtaining clearance to sell, not merely submitting to FDA or a notified body to "start the reviewing clock". Beyond domestic and European submissions, Keystone Regulatory Services can ensure that you obtain timely approval to sell in Canada and the rest of the world.

Keystone Regulatory Services, LLC

Premarket Regulatory Strategy