Post-market Activities
To ease your regulatory work and to free internal resources, we offer you a continuous service to maintain technical documentation up to date and to monitor the safety and performance of your device following its release onto the market.
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Post-Market Surveillance (PMS) Service
We can compile the PMS Plan, carry out the scheduled activities and produce the PMS Report or Periodic Safety Update Report (PSUR). Subsequent updates to device technical documentation, risk management, and labelling can be done by us.
Post-Market Clinical Follow-up
We can compile the PMCF plan, perform the activities as scheduled, analyze and report the findings, supporting you to implement any preventive or corrective measures, and update the clinical evaluation plan/report. When required for your implantable or class III medical device the Summary of Safety and Clinical Performance (SSCP) may be drawn up and updated by our experts.
Post-Market Performance Follow-up
We can compile the PMPF plan, perform the activities as scheduled, analyze and report the findings supporting you to implement any preventive or corrective measures, and update the performance evaluation plan/report.
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