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REGULATORY SERVICES
Psephos has decades of experience obtaining regulatory approvals for medical devices. We help clients develop a regulatory strategy with an action plan, which we can help implement.
Services include:
- Regulatory Strategy
- Device Classification
- UKCA Marking
- CE Marking
- Technical File Preparation, GAP Analysis and Updates
- Notified and Approved Body Selection
- Determining Device Testing Requirements
- Assistance with engaging and selecting test houses
- Executive Level Regulatory Coaching
- FDA Guidance
BROCHURE
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