Medical Device Pharmacovigilance - Overview
Post-marketing Surveillance (PMS) for medical devices or medical device vigilance is the practice of monitoring the safety of a medical device. PMS is also known as medical device Pharmacovigilance.
PMS requirements vary between different medical device markets, which requires manufacturers to develop a targeted strategy and avoid a one-size-fits-all approach. The EU requirements for post-market surveillance for medical devices differ significantly from that of the US.
With proven expertise in medical device Pharmacovigilance or PMS Regulatory support, Freyr can help organizations develop the ideal PMS strategy based on the risk profile.
Freyr provides Pharmacovigilance and medical device vigilance services and supports electronic reporting of medical device incidents by using 3500A, preparation, design, execution, and submission of the post-market surveillance for medical devices for the US FDA and EU MDR, trend reporting, analysis of serious incidents & field safety corrective actions, analysis of medical device vigilance data, etc.
Freyr also helps in Pharmacovigilance for medical devices by determining when the incidents can be reportable and ensures the completion of medical device vigilance reports on time per the local requirements. Medical device Pharmacovigilance includes reports having 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.
Medical Device Pharmacovigilance - Freyr Expertise
- Medical device vigilance system.
- Post-market surveillance plan and system that include customer complaints, Medical Device Vigilance Reporting (Vigilance MDR), unsolicited user feedback, maintenance/service reports, and device misuse/compatibility issues.
- Medical device risk management.
- Post-market Surveillance Reports (PMSR/PSUR).
- Post-market Clinical Follow-up (PMCF) plans and evaluation reports.
- Summary of Safety and Clinical Performance (SSCP).
- Post-approval studies for the US FDA.