Whitepaper
Medical Devices

Medical Device Lifetime

Assisting manufacturers in specifying the lifetime of a medical device based on its design characteristics to meet the regulatory requirements of MDR.

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Addressing the lifetime requirements of the MDR (EU) 2017/745.

This paper will focus on the lifetime requirements of the MDR (EU) 2017/745.

Definition of lifetime.
Characteristics affecting Lifetime and risk management.
Documenting lifetime claims & Other sources of lifetime requirements.
Lifetime and device lifecycle.
Lifetime design tools.
Lifetime and device classification & Lifetime and post-market surveillance.

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