MDR assessment

Assessment

Technical Documentation within the MDR conformity assessment procedure

Technical Documentation within the MDR conformity assessment procedure

ASSESSMENT

The MDR Technical Documentation assessment and the resources needed are planned in accordance with the chosen timeline of your service. To ensure adherence to the scheduled timelines for the first and second round of reviews resources are planned in consultation with the conformity assessment experts.

The timelines given are target timelines from the planning model. Individual timelines may differ.

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remote auditing
Infographics

Remote medical device auditing guide

Understanding the basics to achieving a successful remote audit

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EU Medical
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EU Medical Device Regulation (cosmetic devices)

By May 2020, every device will need to comply with the MDR.

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New Medical Device Regulation
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The Medical Device Regulation

Understand the requirements of the MDR

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