Technical Documentation
Peritus utilises collaborators who have worked for both manufacturers and Notified and Approved Bodies. They have in-depth experience in a wide range of medical devices and regulatory regimes.
- Creation of CE/UKCA technical documentation, including medicinal and animal substances
- Gap analysis of a draft/existing technical file/design dossier
- 510(k) applications
Clinical Services
- Literature searches
- Clinical Evaluation Reports / Performance Evaluation reports; medical writing services
- Summary of Safety and Clinical Performance / Summary of Safety and Performance