Overview

Post Marketing Surveillance (PMS) is the practice of monitoring the safety of a medical device after it has been released in the market. PMS guidelines are a collection of processes and activities used to monitor the safety and effectiveness of medical devices. These activities are designed to accurately characterize real-world device performance and clinical outcomes and generate information to quickly identify low-performing devices and other safety problems. The PMS including clinical follow-up, complaint and vigilance handling, impacts all aspects of the quality management system (QMS).

To counter these challenges, Freyr provides proven Regulatory support to track and maintain quality PMS throughout product life cycle to ensure continued compliance within the ambit of region-wise guidelines and also assists in time-to-time Regulatory course corrections.

Freyr Expertise

  • Leverage PMS data to support compliance with the new regulations
  • Evaluate existing PMS data and ensure that existing processes and outputs are robust
  • Monitoring and reporting practices in response to fast changing Regulatory environments in MENA, LATAM & APAC countries
  • Regulatory support for the review and compilation of the annual reports, post-market surveillance reports
  • Plan and implement the post-market clinical follow-up activities
  • Identify the requirements of the European medical device directives (90/385/EEC, 93/42/EEC, 98/79/EC), standards and guidance documents to enable effective implementation of a post-market surveillance system
  • Support for product recall, complaint handling and medical device reporting as per FDA 522
  • Implement cost-effective and targeted post-market clinical follow-up
  • Updating the clinical evaluation summaries on timely basis
  • Recognize when a complaint need to be reported as an incident
  • Development of user manuals/quick start guides, post-market customer feedback (surveys)

Freyr Advantages

  • Timely and accurate information on the benefits and risks of medical devices throughout their market life using high quality, standardized, structured, and electronic health-related data
  • Proactive monitoring of market, and regulation updates
  • Identifies potential safety issues in real-time from a variety of privacy-protected data sources
  • Continuous collection, analysis and delivery of PMS data
  • Initiate appropriate product recalls on time as per the requirements
  • Utilize post-market data effectively for business benefits
  • Reduced burdens and cost-effective approaches of medical device post-market surveillance
  • Facilitates the clearance and approval of new devices, or new uses of existing devices