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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

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