Mammography or Mammographic x-ray systems are familiar
to us.
For years Compliance Consultants worked directly for and reported solely to - one of the founders of a major mammography system provider. The founder once remarked that ....our prototype was better than what his own people produced in their labs.
Compliance Consultants submitted the application for one of the early pressure driven biopsy needles.
Regulation Number: 21 CFR 892.1710, Product Code: IZH
The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13.
http://www.fda.gov/downloads/MedicalDevices/DeviceRegu lationandGuidance/GuidanceDocuments/UCM185904.pdf
For years Compliance Consultants worked directly for and reported solely to - one of the founders of a major mammography system provider. The founder once remarked that ....our prototype was better than what his own people produced in their labs.
Compliance Consultants submitted the application for one of the early pressure driven biopsy needles.
Regulation Number: 21 CFR 892.1710, Product Code: IZH
The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13.
http://www.fda.gov/downloads/MedicalDevices/DeviceRegu lationandGuidance/GuidanceDocuments/UCM185904.pdf
