The medical device industry has an ever-demanding set of regulations to follow, we at JCIPL are a team of medical device industry professionals offering our expertise in Post-Market Surveillance (PMS) to comply with EU MDR, Swiss MedDO, FDA, TGA, MHRA, Health Canada, PMDA and more such global regulations. The authorities mentioned above and manufacturers of medical devices are both focused on patient safety; hence, the market has shifted from reactive to proactive measures in PMS. Getting approvals for a medical device to enter the market is not sufficient, it is essential to ensure the safety and performance of the device as long as it is in the market.
EU MDR has introduced the Periodic Safety Update Report (PSUR) requirement. The medical device manufacturers of Class IIa, Class IIb, and Class III devices are compiled to prepare PSUR for the respective medical devices. Need help with PSUR Report, connect with our expert today.
PSUR report should contain
- The results of Post Market Clinical Followup
- Summary & results of Post Market Surveillance activities
- Description of preventive and corrective actions taken
- Evaluation of benefit-risk determination
- Trend reporting
- Volume of Sales
- An estimate of the user population
- Usage Frequency
JCIPL holds expertise in conducting efficient Post-Market Surveillance. Our team of highly experienced professionals has worked in this industry for many years with global leading medical device companies. This experience is crucial for robust Post- market Surveillance. We have a deep understanding of regulatory requirements laid by all the different countries, majorly the US and Europe. JCIPL provides end-to-end Post-Market Surveillance solutions.
PMS planning, report & technical file management
Adverse event reporting, CAPA & complaint handling
Risk management and technical file management
Post market clinical followup (PMCF)
PMS planning, report & technical file management
- PMS Planning: PMS Procedure and PMS Plan
- PMS Report: PMS/ Periodic Safety Update Report (PSUR Report)
Adverse event reporting, CAPA & complaint handling
- Complaint Handling: Complaint Review, Complaint Investigation, Determination of CAPA if needed, Root-Cause Analysis, Response to Complaint, Complaint Closure
- Adverse Event Reporting: Vigilance Reporting, Trend Reporting, Field safety corrective actions, Field safety notice.
- CAPA Problem Identification, Root Cause Analysis, Corrective and Preventive Action Plan, Verification of Implementation, Closure.
Risk management and technical file management
- Risk Management: Impact Assessment, Review and update risk assessment
- Technical File: Impact Assessment, Review and update risk assessment
Post market clinical followup (PMCF)
- Registry studies: Medical device registry studies
- Literature Review: Clinical literature review
- Survey Questionnaire: PMCF User Survey questionnaire
- Database Study: Publicly available database study
- Clinical study
