Warning Letter – Crystal Medical Technology – Dental Implants

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

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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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Partners located in the US (CA, FL, MA, MN, TN) and Italy.