Post Marketing Surveillance (PMS) for Medical Devices - MakroCareRegulatory, Clinical Consulting Services to Biopharma & Medical Device Companies

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 post marketing experts combine your product goals with our deep experience (Technical, Engineering, medical, safety, regulatory, and quality) to ensure PMS activities are managed in compliance with country specific regulations.

Proactive monitoring of complaints to assess risk and suggest manufacturers on activities (strategic and tactical)
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