According to the European Medical Device Regulation (MDR), manufacturers have to provide clinical data for their medical devices after they have been placed on the market.
The planning and implementation effort for suitable follow-up measures (PMCF) is increasing, not only for medical devices that are to be newly CE-certified, but also for medical devices for which re-certification is pending.
Manufacturers should develop PMCF plans that include all PMCF activities for the expected life cycle of their devices.
Dr. Schorn Consulting creates or updates your clinical evaluation according to MEDDEV 2.7 / 1 rev. 4 and MDR.
Dr. Schorn Consulting designs the PMCF measures that are appropriate for you and carries them out for you, from planning to report.
In cooperation with you, Dr. Schorn Consulting updates your QM system, especially in the CEP / CER processes or the PMCF process.
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