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.
Contact us to discuss your premarket strategy requirements.