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