- Overview
- Business
- Development
- Testing, V&V
- Design Control
- Quality Systems
- Clinical Trials
- Regulatory
MedDevice Strategies’ principals have accomplished IDE and PMA approvals with the FDA, CE Mark approvals with the European Union, and approvals with other countries in the Rest of the World. This photograph shows an example of an IDE submission for an implantable device. There are many aspects to a successful submission including comprehensive strategy and organization with complete and clear presentation.
Regulatory Affairs
US, Canada, European and Japan experience
Regulatory strategy definition
Drafting, reviewing submissions/dossiers
Negotiations with regulatory bodies
Event Reporting
Study protocols
Study site administrative negotiations/interactions
Regulatory strategy definition
Drafting, reviewing submissions/dossiers
Negotiations with regulatory bodies
Event Reporting
Study protocols
Study site administrative negotiations/interactions