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22 June 2012

Risk Management for Medical Devices - A Practical Approach

By Val Theisz

Imagine yourself in this situation: you just started working for a new company and you review the risk management file you need to include in the next device submission. After recognizing that the risk management process itself is deficient, should you bite the bullet and address this more fundamental issue first, but risk delaying the submission in exchange for mid- and long-term benefits? If you decide this is the best course of action for you and your company, this article is for you. [Read More...]

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510(k)

Design History File

ISO 14971

medical device

risk

Risk Management File
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Risk Management for Medical Devices - A Practical Approach

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