Only in everyday clinical practice can the safety and efficacy of a medical device be seen. Clinical post-market surveillance (PMCF) is therefore of extreme importance.
The versatile use of PMCF data
The MDR (Medical Device Regulation (EU) 2017/745) requires you as a medical device manufacturer to proactively and systematically collect and evaluate data from the regular clinical use of your medical device. PMCF data are incorporated into the clinical evaluation of your product.
However, PMCF should not only be considered an obligatory part of technical documentation. The PMCF can also provide valuable impulses for future product developments or form the basis of an expansion of indications. Furthermore, the clinical data gained may also be used in scientific marketing.
Individual solutions for individual problems
From our 20 years of experience as a contract research organization for medical technology, we know that every medical device requires an individual PMCF concept. Possible PMCF measures range from a clinical user survey to the creation of a registry or a comprehensive PMCF study. Our experts will work closely with you to develop the appropriate PMCF strategy for the continuous monitoring of the clinical safety and performance of your medical device.
- Consultation regarding design, implementation and evaluation of PMCF measures
- Development of an individual PMCF strategy for your medical devices while taking into account scientific marketing issues
- Development of MDR-compliant PMCF plans
- Implementation of PMCF measures, including related services such as document preparation, data management or communication with governmental agencies
- Evaluation of PMCF measures
- Revision of the clinical evaluation based on the results of PMCF measures
Contact your novineon specialist.
Phone: +49 7071 98979 – 127