Do you know how to handle complaints regarding your medical device?
Medical device companies that market their devices in Europe or the United States must establish a customer complaint handling process to comply with regulatory quality standards. In the U.S., medical device quality systems are regulated by 21 CFR Part 820, the medical device quality system regulations. Complaints that warrant Medical Device Reports (MDRs) should be filed with the FDA in accordance with 21 CFR Part 803. Medical device manufacturers can find the full requirements for complaint handling under 21 CFR § 820.198.
QA Consulting CEO, Anne Holland, participated on an informative panel discussion about the Trials and Triumphs of Medical Device Complaint Handling, hosted by Greenlight Guru. Wade Schroeder of Greenlight Guru moderated the panel that included QA Consulting CEO Anne Holland, Murtuza Bohari, Quality and Regulatory Manager at Canterbury Scientific, Limited, and Joanne Lebrun, Vice President of MDC Associates. Participants responded to a variety of key topics on complaint handling, including best practices, measurement, managing data, training, teamwork and key recommendations. Watch here: