Post-market clinical follow-up (PMCF) is an important requirement under the EU Medical Device Regulation (MDR) for continuously evaluating the safety and performance of medical devices on the market. PMCF objectives include confirming the overall safety and performance of the medical device, as well as identifying risks and systematic misuse. The design of the PMCF study must be documented in a plan, and the results are presented in a report, which is used to update the Clinical Evaluation Report (CER).
Learn more about the regulatory requirements for PMCF and practical tips for carrying out PMCF activities by joining the next BSI Clinical Masterclass:
At Scandinavian CRO, we have the medical device expertise to help you with all aspects of your clinical investigations from planning, designing, and executing through to analysis and reporting. Contact us
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
The _ga cookie, installed by Google Analytics, calculates visitor, session and campaign data and also keeps track of site usage for the site's analytics report. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors.
This cookie is installed by Google Analytics.
A variation of the _gat cookie set by Google Analytics and Google Tag Manager to allow website owners to track visitor behaviour and measure site performance. The pattern element in the name contains the unique identity number of the account or website it relates to.
Installed by Google Analytics, _gid cookie stores information on how visitors use a website, while also creating an analytics report of the website's performance. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously.
YouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data.