Day

August 7, 2015
Mylan.Product: ECG Check Application and ECG Check Wireless Lead Cardiac Monitor Date: 8/7/2015 1. Failure to establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g). 1. Your...
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John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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