The medical device industry has an ever-demanding set of regulations to follow, we at SARACA 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.
SARACA 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. SARACA provides end-to-end Post-Market Surveillance solutions.
PMS Planning, Report and Technical File Management
PMS Planning: PMS Procedure and PMS Plan
PMS Report: PMS/ Periodic Safety Update Report (PSUR Report)
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.
Adverse Event Reporting, CAPA and Complaint handling
Risk Management and Technical File Management
Risk Management: Impact Assessment, Review and update risk assessment
Technical File: Impact Assessment, Review and update risk assessment
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
Post Market Clinical Followup (PMCF)
CLIENT TESTIMONIALS
We work continuously to receive customer feedback to provide them unmatched value. Here is what they say about us.
“Toby has had a smooth journey with Saraca Solutions. They have provided us with both a highly experienced Quality Manager and a very energetic Quality Engineer. Specifically, I would like to thank Saraca for closing our NCs in a timely manner while simultaneously performing a gap analysis on our entire QMS. Additionally, in preparation for an upcoming ISO audit, Saraca performed an internal audit on all of our major Quality subsystems. Lastly, Saraca Solutions faced our 2017 ISO audit, hand in hand with our staff, at Toby headquarters. I appreciate the end to end support provided by Saraca Solutions. This magnitude of interaction is unique among engineering services companies in the area of medical devices."
"Saraca was extremely helpful to our Product Team’s understanding of the requirements of ISO 13485 by presenting it to them in a simple and effective manner. They have also done a commendable job in helping us to align our deliverables in-line with the ISO 13485 requirements. With their help, our team was able to understand & implement the ISO 13485:2016 requirements effectively within a short duration. Their planning and execution methodology is superb. Overall, we are very happy with the outcome of our association with Saraca Solutions."
“Our team has partnered well with SARACA Solutions as we continue the development process for submitting one of ENT products for 510(k) review with US FDA. They constructed and maintain a Design History. They are also working on Risk Analysis as defined by our Quality Management System. The SARACA team has shown the depth of their experience working in the industry while seamlessly integrating well with us. In addition, their methods of collaboration ensure effectively developing the documentation and processes for our product management.”
