OUR SERVICES

Strategy

  • Clinical Strategy

  • Regulatory Strategy 

  • Quality Strategy

  • Compliance Strategy

Regulation

  • Medical Device Regulation Gap Analysis

  • Technical File Preparation and Updates

  • Device Registration 

  • CE Marking & Recertification

  • FDA Approval

  • UK Responsible Person

  • UKCA Marking 

Clinical

  • Clinical Evaluation Reports 

  • Clinical Evaluation Plans

  • Clinical Trial Strategy, Design and Management  (ISO 14155)

  • Post Market Clinical Follow-Ups (PMCF) including registries

  • Post- Market Surveillance (PMS)

Quality

  • ISO 13485 Quality Management Systems Development, Implementation and Compliance

  • FDA QSR Quality Management Systems Development, Implementation and Compliance

Operations

  • Risk Management - ISO 14971

  • Product Development and Manufacturing

  • Provision of Executive management and oversight

  • Project management

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Tel: +44 1273 704 527