A product issue could lead to serious health consequences, including loss of consciousness, bleeding, fluid buildup around the heart and death.
The manufacturers failed to comply with requirements related to post approval studies and good manufacturing requirements, respectively.
How in touch are you with current MDR guidelines?
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.