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Post Market Surveillance

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