The Quality System Regulation (QSR), for production and process controls, (21 CFR, Part 820 – Subpart G, Section 820.70) is in the opinion of Dr. D one of the more salient requirements of the regulation.
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.
The proverbial rubber meets the road when the actual execution of test protocols commences. In this edition of Devine Guidance , Dr. D will continue with his dissection of 21 CFR, Part 820; Section 820.30, subsection f (design verification) and subsection g (design validation).
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…
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.