Overview

Post Marketing Surveillance (PMS) of medical devices is the practice of monitoring the safety of a medical device after it has been released in the market.

PMS requirements vary greatly between different Medical Device markets, which necessitates device manufacturers to develop a targeted strategy and avoid one-size-fits-all approaches. The EU Post Market Surveillance (PMS) requirements differ significantly from that of the US Post Market Surveillance (PMS) requirements.

With proven expertise in the PMS Regulatory support, Freyr can help medical device organizations in developing the PMS strategy for the devices, based on the risk profile.

Freyr also supports electronic reporting of medical device incidents using 3500A, preparation, design, execution and submission of the PMS plan for the US FDA and EU MDR, trend reporting, analysis of serious incidents and field safety corrective actions, analysis of vigilance data, etc.

Freyr helps in determining when can the incidents be reportable and also ensures vigilance reports are completed on time as per the local requirements. Reports include Post Market Safety Report (PMSR) – Class I Medical Devices Periodic Safety Update Report (PSUR) - Class IIa, IIb, III, notified body assessments on PSUR’s, MDR reporting- 3500A Form etc.

 

Freyr Expertise

  • Medical Device Vigilance
  • Post-Market Surveillance Plan and System that includes Customer Complaints, Medical Device Reporting, Unsolicited User Feedback, Maintenance/Service Reports, Device Misuse/Compatibility Issue
  • Medical Device Risk Management
  • Post-Market Surveillance Reports (PMSR/PSUR)
  • Post-Market Clinical Follow-up (PMCF) Plan and Evaluation Reports
  • Summary of Safety and Clinical Performance (SSCP)
  • Post-approval Studies for the US FDA