14
Jan
2003

Siemens Medical Solutions USA Inc.

0

Company: Siemens Medical Solutions USA Inc.
Product: Diagnostic x-ray system
Date: 1/14/03

You are requested to report the results of your investigation and follow-up action to this office within thirty (30) working days of receipt of this letter. Your response should include the date that the corrective action was completed and copies of service records and/or other supportive documents. If you do not respond within thirty (30) working days, the FDA may consider you to be in violation of the Act, Sections 538(a)(2) and 538(a)(4) of Subchapter C – Electronic Product Radiation Control (formerly the Radiation Control for Health and Safety Act of 1968).

FDA District: New England District Office

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

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2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

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