Regulatory Affairs Services
Services during the development and registration phase of medical devices.
Managing regulatory risks
- Flag, mitigate, define fallback options
- De-risking activities may include pre-registration interactions with, e.g., FDA and notified body
Decrease certain business risks
Medical device documentation
- Preparation of RA deliverables
(e.g., definition applicable regulatory and normative requirements, classification) - Review of the device documentation
- Technical writing
Ensure smooth registration process
Regulatory submissions
- Definition of regulatory strategy
- Pre-submission meetings with FDA (incl. preparation of briefing package, meeting materials and meeting minutes, as well as conduct of meeting)
- Preparation and submission of regulatory submission files
- Management of deficiency reports
Obtain regulatory approval
