Tag Archives: Section 820.30

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

Design Transfer, Design Changes and Design History File

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

In this fourth and final foray into Subpart C – Design Controls, Dr. D will review the last three subsections; (h) design transfer, (i) design changes, and (j) the design history file (DHF), located within section 820.30. These final three elements of design control are just as important as the previous subsections dissected as part of Devine Guidance.

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Devine Guidance

Design Input, Output, and Review

By Dr. Christopher Joseph Devine
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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
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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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