By Stewart Eisenhart, Emergo Group
The International Medical Device Regulators Forum (IMDRF), the successor organization to the Global Harmonization Task Force, has proposed draft criteria (PDF) for use by medical device market regulators to recognize qualified auditing organizations.
The draft proposal targets auditing processes conducted as part of conformity assessments as well as of post-market surveillance procedures; IMDRF members aim to establish a common list of criteria regulators can use to recognize or designate entities performing auditing services that cover medical device manufacturers. If adopted, the criteria could drive greater uniformity and efficiency in medical device quality system audits across global medical device markets.
Recognition criteria proposed by the IMDRF include normative ISO requirements as well as IEC document ISO/IEC 17021:2011.
Proposed requirements for auditing organizations would include: