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Risk Management

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Guest user Created:   Nov 08, 2023 Last commented:   Nov 08, 2023

Risk Management

Our company has no prior risk management documents on any devices to prepare the risk management packages. I was thinking if I can help engineers by having some samples of similar devices to ours? What is your thought on it?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Nov 08, 2023

This is a good approach. The point is that these similar devices should have a similar intended purpose and be produced by similar technological processes. 

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Nov 08, 2023

Nov 08, 2023