September 15, 2017

Sep

FDA PMA Critical to Quality Pilot Program

September 15, 2017Amy SellersNews

The PMA CtQ pilot program aims to evaluate device design and manufacturing process quality information early on, giving the applicants the option of foregoing the standard PMA pre-approval inspection

Sep

FDA Recognizes AAMI TIR69 Wireless Coexistence

September 15, 2017Alan KusinitzNews

"AAMI TIR69: Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems" available for purchase

Sep

FDA PMA Critical to Quality Pilot Program

September 15, 2017Alan KusinitzNews

Participation in the PMA CtQ pilot program is voluntary and the program aims to evaluate device design and manufacturing process quality information early on to assist FDA in its review of the PMA manufacturing section and post-approval inspections. This voluntary pilot program is part of the FDA’s ongoing Case for Quality effort to apply innovative...

FDA PMA Critical to Quality Pilot Program

FDA Recognizes AAMI TIR69 Wireless Coexistence

FDA PMA Critical to Quality Pilot Program

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FDA PMA Critical to Quality Pilot Program

FDA Recognizes AAMI TIR69 Wireless Coexistence

FDA PMA Critical to Quality Pilot Program

SoftwareCPR Training Courses:

Subscription Services

Corporate Office