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Postmarket Surveillance Service (PMSS)

Quality is an ever-growing problem in the field of medical products, including medical devices, medical diagnostics, pharmaceuticals, dietary supplements, and combination products. Its negative impact is felt by manufacturers as well as their patients, employees, and investors. As the globe's dependence on medical products continues to heighten, as does the trend toward pervasive personalized medicine, the avenues of postmarket quality are getting harder for many firms to navigate, which can be attributed mainly to inadequate quality reporting and analysis infrastructure on behalf of the manufacturers.

Regulatory bodies across the globe impose regulations and guidelines for manufacturers on what their postmarket surveillance program shall cover, including complaint handling/investigations and reporting serious injuries/deaths (e.g., Medical Device Reports, Vigilance Reports). These regulations require a company to actively seek postmarket data, and analyze the data to confirm the existing risk management profile of the product is consistent with the expectations of the company. This postmarket program and the analysis of postmarket data must be incorporated into the technical documentation, including the product family’s clinical evaluation report. Without an adequate PMS program, serious regulatory actions can be taken against a company. In the US, Warning Letters related to Product Complaint handling are the second most frequently cited observation.

With a better recognition of the value of postmarket data and with proper support and resources, a medical products company can better protect patients and respond more quickly to quality issues while complying with the regulatory bodies.

Our Post-Market Surveillance service will create many benefits for our clients.

  • The ability to confidentially work with your complaint handling initiatives and to solve your complaints or Adverse events assuring the language used in the complaint is accurate and balanced
  • Being vigilant about how we portray events
  • Providing administrative overhead and regulatory expertise
  • Quicker allocation of resources with a lower cost, as we can provide a trained worker that doesn’t require startup time, health insurance or benefits from the Company
  • Based on complaint analysis and trend analysis we will provide feedback to the risk management process (e.g., Updating Failure Modes and Effects Analysis)
  • Much more effective trend analysis using empirically validated data
  • Where we see trends, we will make sure they are entered into their CAPA program
  • International regulatory expertise
  • Ability to easily assist with other integrated RQMIS services quickly

How can RQMIS help you with Postmarket Surveillance?

RQMIS can help you establish (or improve upon) a comprehensive post-market surveillance program that includes both proactive and reactive monitoring of product use and feedback.  These services include: 

  • Properly categorizing and processing customer/employee feedback, repair processing, complaints 
  • Serious injury/death reporting (e.g., MDR and Vigilance Reporting) 
  • Health Hazard Analysis/Reports 
  • Recalls 
  • Postmarket Clinical Follow-up (PMCF) Studies 
  • Review and analysis of published and unpublished clinical studies/experience 
  • Clinical Evaluation Reports 
  • Updating and maintaining the risk management profile of a family of products based on a comprehensive review of postmarketing data.
  • Technical Documentation for CE Marking, including product labeling 
  • Trend analysis of Post Market data to determine the potential need for CAPAs 
  • Review of clinical experience to determine potential new uses of existing products


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.