There are many ways to collect these real-world post-market data, and it is vital to be able to justify which approach(es) is optimal for a given medical device. There are 2 aspects to consider:
PMCF Surveys offer a compliant, simple, timely and cost-effective means of RWD collection, especially for well-established technologies with lower risks of clinical gap exposure.
PMCF surveys must be scientifically justified, and the type of survey will depend on the type of medical device, including the risk classification and previous data obtained. Surveys can be used alongside other PMCF activities to strengthen pool of clinical evidence for all risk classes.
Whether an end-user or patient survey, high quality data may be collected provided that
- Identify clinical claims made by the manufacturer
- Define outcomes to measure
- Decide whether additional PMCF activities are required
- Evaluate the acceptability of the benefit-risk ratio
At Evnia, we support our partners throught the implementation of their PMCF strategies including the development and deployment of high-quality PMCF surveys. A cross-functional team conducts a gap assessment analysis to identify the optimal type of PMCF Survey and its respective objectives, prepares the PMCF survey protocol and the customized questionnaire, deploys the survey and analyzes the data.
Being the Strategic Alliance Partner of Smart-Trial by GreenLight Guru, we ensure:
We are here to assist. Contact us by phone, email or via our Social Media channels (Twitter or LinkedIn).