Post Market

Surveillance

We customize our services to accommodate each client’s needs and specific challenges.

human-factors-engineering

evidence-based-instructional-design

regulatory-guidance

postmarket-surviellance

line

Post Market Surveillance

 
Agilis uses a usability-centered post market data mining of complaint files and MDR reports to provide clients with a structured method of identifying trends in device use problems. We use a systems query language approach to isolate competitor and client device use problems useful in both next-generation design and risk assessment.

  • Evaluation of Medical Device Reports (MDR) and Adverse Events (AE)
  • Guidance on human factors engineering activities for future avoidance
  • Documentation upgrades and training

Human Factors Experts

The Agilis process prepares our clients to answer Regulatory’s most fundamental bottom line question: “Show us the body of evidence that provides a compelling, comprehensive and valid case that your device and IFU support safe and accurate user performance.”