Post-Market Surveillance for Medical Devices


ICON's medical device team, in collaboration with our HEOR practice, has the expertise to help you successfully commercialize your product. We develop holistic approaches that allow you to generate the evidence needed to evolve market share, meet increasingly burdensome payer requirements, and reduce the costs of conducting post-approval studies and observational research.

See how we design and implement strategies that maximise return on investment and minimise the financial impact of conducting a post-approval study.

Case Study 1: Rapid Post-Market Study Start-up

An unanticipated request from a notified body required a Fortune 500 medical device manufacturer to conduct a post-market study for its new cardiovascular device. In order to meet the aggressive timeline, the manufacturer enlisted ICON's Medical Device & Diagnostics Research group. With ICON's highly efficient approach, the company was able to beat enrolment timelines, meet the notified body's strict deadline, and reduce planned study costs by almost 25%.

Case Study 2: Seamless Transition from PMA to Post-Market

When an orthopaedics manufacturer was required to conduct a post-market study for an innovative device, ICON seamlessly transitioned 600 patients and 24 sites from an ongoing trial supporting a PMA application to the required post-approval study. By preserving site relationships and CRO staff, ICON succeeded in executing an efficient and cost-effective post-market study with strong retention rates.