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  • 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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Using Standards to Demonstrate Conformity - Asian scientist people in laboratory for online data analytics
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Using Standards to Demonstrate Conformity

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