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.
The identification and traceability (sections 820.60 and 820.65) for products and finished medical devices, throughout the entire manufacturing process, including raw materials employed during the manufacturing process, and the subsequent sale and distribution of medical devices, are critical elements of the Quality System Regulation (QSR).
FDA is really taking medical device manufacturers to task in regards to purchasing controls and the overall management of their suppliers. According to Kimberly Trautman, FDA’s current Good Manufacturing Practices (cGMP) and Quality System Regulations (QSR) expert, suppliers providing non-conforming material are directly related to an increase in medical device recalls; which increases the need for effective quality processes to mitigate risk. As the medical device industry continues to grow in leaps and…
The control of documentation is one the fundamental cornerstones supporting the foundation needed for an effective quality system, whether compliance is to EN ISO 13485, EN ISO 9000, the Medical Device Directive, or in the case of this series of Devine Guidance articles, the Quality System Regulation (QSR).
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…
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.
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.
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…
The Food and Drug Administration (FDA) will evaluate the effectiveness of your internal quality audits and review the corrective actions pursued as part of the overall quality audit system. If a nefarious approach to executing quality audits is pursued, the reward will be a Form 483. If the FDA feels the violation is egregious, a warning letter will be forthcoming. In monopoly speak, “do not pass go and do not collect your two hundred dollars.” Warning letter violations As you can see by the abundance o…
