Post Marketing Surveillance (PMS) of Medical Devices is a systematic procedure carried out to actively monitor (collect and review) the safety of medical devices that are already in market. Post Marketing Surveillance is a collection of processes & activities used to ensure quality, safety, and performance of the device using real world data from market to accurately characterize device performance & clinical outcomes throughout the lifetime of the device.
Our Role
- Guides device manufacturers in conducting the PMS
- Develop risk profile based Post Market Surveillance strategy for the medical device
- Identify EU MDR - PMS, IVDR - PMS, ISO 13485-2016, 21 part CFR and guidance documents requirements to enable effective implementation of a Post Market Surveillance system
- Evaluate current PMS data and draw suitable conclusions to ensure compliance with the new regulations in target markets
- Provides well-structured PMS plan, procedure and report templates
- Prepare vigilance reports in compliance with local requirement with timely delivery
- Regulatory support for the review and compilation of the annual reports, Post Marketing Surveillance reports
- Corrective and Preventive actions (CAPA) Management
- Support for product recall, customer complaint handling and Medical Device reporting- country specific regulations
- Identifies PMCF requirements from PMS data
- Medical Device Registration and investigation support, Case and exposure management and Adverse event follow up
- Post-marketing literature surveillance.
- Regulatory assessment and diagnostic reporting.
Why MakroCare?
With 20+ years experience, our global regulatory experts combine your product goals with our deep experience (pre-clinical, clinical, CMC, safety, and quality) and scientific depth on similar approvals to create a solid regulatory strategy.
- Proactive monitoring and implementation of Regulatory updates or changes
- Seamless transition from PMA to PMS
- Continuous collection, analysis and delivery of PMS data and utilize effectively for business benefits
- Cost-effective approaches of Medical Device PMS
The First Step
Let's talk about how MakroCare can help you