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Monitoring of medical devices placed on the market
Post Market Surveillance
We support you with state-of-the-art simulation technology so that your medical device remains beneficial and safe on the market.
Benefits for you
Better objectification of performance and safety as well as possible risks
Efficient evidence generation for post market clinical follow-ups on the function and safety of medical devices
Effective support for defect analysis as well as rectification in case of necessary corrective actions (CAPA) and product failures
Objective assessment of your medical devices in the patient
According to the latest regulatory requirements, every medical device manufacturer is obliged to proactively and continuously monitor products placed on the market and document their performance. For this purpose, regular reviews of function, safety and quality must be performed and any risks identified.
On the basis of purely clinical observations, it is difficult to generate sufficient evidence in this context. This is especially the case when necessary corrective measures or even product failure are imminent. This is where simulation provides objective data for performance and safety evaluation on a scientific-biomechanical basis. This means that effective countermeasures and product improvements can be achieved even in the event of damage.
Our offer to you
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ABOUT CADFEM Medical
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