Tag Archives: EN ISO 13485:2003/AC2007

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

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

Supplier Maintenance Assessments

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

If a supplier scored well on their original selection assessment, or scores well on repeat maintenance assessments—say, a score of 90 percent or above for argumentative sake—and your organization is receiving 100 percent conforming product (yes, imagine a perfect world), what is the value of performing an annual or regularly scheduled maintenance assessment? Dr. D does not see any upside. Now I could write a philippic (yep, look up time again) that takes medical device organizations to task in regards t…

Continue reading

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

SCARs and Rules

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

Welcome back to this sixth installment of Devine Guidance . I am not one to assume a Panglossian view (time to pull out the dictionary again) when dealing with problem suppliers and the need to pursue corrective action. However, at times the ugly SCAR becomes unavoidable. In fact, evidence of effective corrective action, as it pertains to suppliers is a requirement and the FDA, notified bodies, and other regulatory bodies will verify the effectiveness of the approach pursued by your organization. Additi…

Continue reading

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

Gage R & R and Reduced RI Programs

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

Since the concept of writing a weekly blog and actually having a following is somewhat foreign to me, I was not sure what to expect or the reception I would receive writing a weekly column. So far, the support and responses have been overwhelmingly positive; and for that, I would personally like to thank the readers. Additionally, I will continue to write about and provide relevant information associated with supplier quality (four installments remaining) and will eventually begin addressing quality and…

Continue reading