Tag Archives: Chris Devine

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

Nonconforming Product

By Dr. Christopher Joseph Devine
No Comments
Dr. Christopher Joseph Devine, President, Devine Guidance International

In this edition of Devine Guidance (DG), the doctor will provide guidance for 21 CFR, Part 820 – Subpart – I, Nonconforming Product, specifically (820.90). The key takeaways for this week are: sticking to procedures; understanding the importance and elements of effective control of nonconforming product; refraining from the UAI disposition; reworking to approved specifications; and maintaining and updating accurate DHRs.

Continue reading

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

Acceptance Status

By Dr. Christopher Joseph Devine
No Comments
Dr. Christopher Joseph Devine, President, Devine Guidance International

In this week’s edition of Devine Guidance (DG), the doctor will provide guidance for 21 CFR, Part 820 – Subpart – H, Acceptance Activities, and specifically (820.86), Acceptance Status. There is really just one takeaway from this week: ensure all devices are properly labeled with the appropriate acceptance status.

Continue reading

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

Acceptance Activities

By Dr. Christopher Joseph Devine
No Comments
Dr. Christopher Joseph Devine, President, Devine Guidance International

In this week’s edition of Devine Guidance , the doctor provides guidance for 21 CFR, Part 820 – Subpart – H, Acceptance Activities, and specifically (820.80), receiving, in-process, and finished device acceptance. Selecting suppliers capable of supporting an effective SSDP, employing statistical tools when performing in-process acceptance activities, completing final acceptance activities before finished devices can be released for distribution, and collecting and placing appropriate information into rec…

Continue reading

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

Inspection, Measuring, and Test Equipment

By Dr. Christopher Joseph Devine
No Comments
Dr. Christopher Joseph Devine, President, Devine Guidance International

Inspection, measuring, and test equipment form a significant part of the quality-system foundation for successful medical device manufacturers. Device manufacturers need effective tools to gage adherence to approved product specifications; and the vehicle employed for doing so is the performance of acceptance activities utilizing inspection, measuring, and test equipment.

Continue reading

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

Identification and Traceability

By Dr. Christopher Joseph Devine
No Comments
Dr. Christopher Joseph Devine, President, Devine Guidance International

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).

Continue reading