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MDR QMS requirements

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Guest user Created:   Nov 09, 2020 Last commented:   Nov 10, 2020

MDR QMS requirements

'm looking at your MDR QMS requirements table and I have a feeling it doesn't refer to all the correct MDR requirements i.e. Resource management (ISO 6) in MDR is states something about the control of suppliers and subcontractors... that's not resource management, same with A strategy for complying with regulations that's not 7.2

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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Nov 10, 2020

Thank you for pointing this out to us. You are right, we will correct it. Control of suppliers and subcontractors is definitively covered by 7.4  Purchasing, and strategy for complying with regulation is in 4.1General requirements and 5.1 Management commitment.

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Nov 09, 2020

Nov 10, 2020

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