Tag Archives: Complaints

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

Complaints (Subsections d and e)

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

Complaints, complaints, and more complaints, extracted from the opening sentence from the previous edition of Devine Guidance, is also an appropriate introduction for this edition DG and Dr. D’s continued diatribe on complaint management covering Subsections ‘d’ and ‘e.’ There is really only one takeaway from this edition of DG, complaints “shall be promptly reviewed, evaluated, and investigated.

Continue reading

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

Complaints (Subsections a, b, & c)

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

Whether major or minor, complaints require a significant organizational commitment to ensure a fastidious and consistent approach to complaint management. This week’s Devine Guidance will begin analyzing and providing insight and guidance needed for maintaining an effective compliant management system–mainly complying with 820.198, subsections a, b, and c.

Continue reading

Building the Clinical Risk Perspective into Medical Device Manufacturing

By Thomas Maeder
No Comments

The evaluation and management of risk throughout the product life cycle is the single most important concept in the regulation of medical devices. Yet it is difficult to define precisely what “risk” means or how to assess it in an industry where some 115,000 devices are produced by thousands of manufacturers, employing a dizzying array of technologies destined for use in varying health settings for every imaginable indication. So who determines the risk, and where do problems typically arise?

The evaluation and management of risk throughout the product life cycle is the single most important concept in the regulation of medical devices. Yet it is difficult to define precisely what “risk” means or how to assess it in an industry where some 115,000 devices are produced by thousands of manufacturers, employing a dizzying array of technologies destined for use in varying health settings for every imaginable indication. So who determines the risk, and where do problems typically arise?

Continue reading