IMDRF Issues Recognition Criteria for Medical Device Auditing Organizations

On 24 October 2012, IMDRF released a draft guideline defining the criteria regulators should use to recognize medical device auditing organizations performing work in their respective jurisdictions. Kim Trautman, associate director of international affairs for FDA, stated that the guideline will, “complement the current ISO13485 revision process under which IMDRF seeks modifications to achieve a harmonized standard amongst its members.”

Mike Ward, manager of Health Canada’s International Programs Division said the harmonization of auditing standards could not be underestimated, and called it the, “future of regulation.” The proposed document, released by IMDRF’s Medical Device Single Audit Program Working Group, is the first such document to be released by the organization, and is being coordinated by Kim Trautman and is now available for comment on the organization’s website.