Day

April 11, 2005
Recipient: Rosenthal Eye and Facial Plastic Surgery.Product: Investigational devices Date: 4/11/05 Our review of the inspection results also noted that you use an electronic medical record (EMR) system to maintain medical and other clinical data for your patients, including study subjects . You told Mr. Steyert that data obtained during study visits are entered directly...
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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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