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Clinical Strategy and Post-Market Surveillance.

Generating and maintaining clinical evidence

Consulting and clinical investigation design activities are carried out under an ISO 9001-certified quality management system to ensure methodological control, document traceability and operational consistency throughout the project lifecycle.

Clinical Investigations (MDR - ISO 14155).

Design and conduct of clinical trials to demonstrate safety, performance, and clinical benefit in pre-market or prospective PMCF.

  • rationale sample size justification
  • Endpoint strategy
  • Drafting Clinical Investigation Plan (CIP)
  • Ethics Committee/Competent AuthoritySubmission.
  • Monitoring and reporting
  • Integration into the ERC
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PMS and Post-Market Clinical Follow-up.

Design and management of the postmarketing surveillance system and ongoing postmarketing clinical data collection.

  • Structured Surveys
  • PMS Plan
  • PMCF Plan & Report
  • PSUR
  • Complaint Analysis
  • ERC Update
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Why FTR Advisor?

FTR Advisor applies an ISO 9001 certified quality management system for consultancy and design of clinical investigations for medical devices

Certificate Number: IT340547
Consultancy and design of clinical investigations in the field of medical devices

Are you looking for an experienced and reliable CRO for medical device consulting?
We design and manage all phases of the clinical investigation through our team of highly qualified professionals.
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