14
Sep
2000

Warning Letter – Crystal Medical Technology – Dental Implants

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0

Crystal Medical Technology 9/14/00 Dental Implant Devices

The inspection revealed deviations from Part 820 including failure to have a manufacturing validation study protocol and to validate software manufacturing equipment and the autoclave sterilization cycle, failure to conduct internal audits, incomplete Device Master Records and Standard Operating Procedures, no Design Plan, no change control procedures and no verification acceptance criteria.

FDA New Orleans District
SoftwareCPR Keywords: production software

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.

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

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