Postmarket Surveillance Service

Medical Market Size is currently worth USD $485.46 billion in 2022 and is trending toward a market size worth USD $964.90 billion by 2030. With that rapid increase, the need for robust Post-Market Surveillance and Clinical evidence is becoming very important to MedTech companies who want to compete for their share of this ever-growing market.

According to a McKinsey study, the direct cost of quality assurance in the medical device industry is USD $26 billion to USD $36 billion annually, and this will continue to grow with the market. In 2022, the medical device industry spent USD $2.5 billion to USD $5 billion annually to address non-routine quality events in the US alone, such as significant observations, recalls, warning letters, consent decrees, warranties, and lawsuits.

McKinsey also reports the cost of a significant medical device recall or other single non-routine quality events can reach USD $600 million.

Having had success with several clients in aiding them with their PMSS Complaint Handling and Adverse Event Reporting initiatives, RQMIS, Inc. has the ambitious goal of introducing a new Complaint Handling and Adverse Event Reporting service to the global market.

This service will allow us to help structure and support a client’s Complaint Handling process and post-market surveillance program. Our goal is to help complete and trend complaints, which will help with product upgrades and improvements, as well as increase client satisfaction. RQMIS will help identify, complete, and submit Adverse Event Reports to satisfy regulations.

RQMIS's Post-market Surveillance Service (PMSS) will have six major services that will facilitate a Company in more efficiently/effectively understanding how well their products are performing in the field and capture opportunities for improvement.


The service areas are:

  • Complaint Handling
  • Adverse Event Reporting
  • Quality Metrics and Trend Analysis

  • CAPA (including recalls 21 CFR 806/810)
  • Health Hazard Analysis
  • Post-Market Clinical Follow-up Studies/Registries

All the above processes will comply with local regulatory requirements to assure compliance with relevant standards such as:

  • Medical Device GMPs – 21 CFR 820
  • MDR – 21 CFR 803
  • ISO 13485
  • ISO 14971

  • MDR for the UK
  • Health Canada

Want to explore what Post-Market Surveillance, including Complaint Handling and Adverse Event/Vigilance Reporting, looks like in your organization? Our experts are ready to show you.

To learn more please call us at 978-358-7307, or just click the button below.