The agency has issued its list of the most common inspectional observations for FY 2017.
Never downplay the importance of customer complaints.
We all talk about cross-collaboration, but do we really practice it?
Discussing device problems can have a serious affect on patients. Physicians, manufacturers, and FDA should clarify their message to maintain trust.
If your establishment is entering equipment into commerce that is deemed a finished medical device and product servicing is expected during the normal product life-cycle, then compliance with §820.200 is mandated by the QSR. Mandatory means “not optional” in the eyes of the regulatory gods at FDA.
Not unlike the inevitability of death and taxes, device manufacturers can expect to receive a complaint or two, or two thousand. The sooner device manufacturers face this reality, the sooner they can develop and deploy effective complaint-management systems that comply with the Quality System Regulation.
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.
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.
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?