Tag Archives: training

Devine Guidance

Design Input, Output, and Review

By Dr. Christopher Joseph Devine

I hope that the readers of DG are able to glean some useful information from Dr. D’s frequent flights of rodomontade (look it up) pertaining to the need for compliance with regulations. As I emphatically opined in the previous edition of DG, medical devices that are safe and effective are born from a robust design and development process. Although I cannot speak on behalf of the agency, it would be a subreption of the regulations if I did not continue to state the overall importance of design control fo…

I hope that the readers of DG are able to glean some useful information from Dr. D’s frequent flights of rodomontade (look it up) pertaining to the need for compliance with regulations. As I emphatically opined in the previous edition of DG, medical devices that are safe and effective are born from a robust design and development process. Although I cannot speak on behalf of the agency, it would be a subreption of the regulations if I did not continue to state the overall importance of design control fo…

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Devine Guidance

Design Control

By Dr. Christopher Joseph Devine

Adhering to a robust design and development process results in a quality medical device that is safe and effective. This installment examines general requirements, and design and development planning of Design Control.

Adhering to a robust design and development process results in a quality medical device that is safe and effective. This installment examines general requirements, and design and development planning of Design Control.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Personnel Training

By Dr. Christopher Joseph Devine
Dr. Christopher Joseph Devine, President, Devine Guidance International

The FDA’s requirements for personnel are delineated within Section 820.25. In fact, Section 820.25 appears to be one of the more innocuous requirements and in the opinion of Dr. D, one of the most important. Can you say training, training, and more training? Regardless, compliance to the requirement is mandated by the regulation. That said, Dr. D would probably suffer from some compunction if I failed to cover all aspects of the regulations as part of this current series. As always, my goal is to enligh…

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