Other Resources
IMDRF/MDSAP WG Documents – Training and Competency Related
The following documents pertaining to MDSAP competence and training were produced by the International Medical Device Regulators Forum (IMDRF).
AO Related Requirements/Guidance
The following two documents are complementary documents focused on requirements for an AO and individuals performing regulatory audits and other related functions under the respective medical device legislation, regulations, and procedures required in its regulatory jurisdiction.
The information provided in IMDRF/MDSAP WG/N4 is supplemented by procedures describing the training required of each auditor who is to perform MDSAP audits, and a summary of competencies expected of auditors and technical support officers involved in the audit process.
Further information on how to become a recognized MDSAP AO is available at Becoming Recognized.
RA Related Requirements/Guidance
The purpose of the IMDRF/MDSAP WG/N6 document is to specify competence and training requirements that shall be demonstrated and maintained by RAs for personnel involved in the assessment of AOs performing regulatory audits of medical device manufacturers.
The purpose of the IMDRF MDSAP WG N11 document is to define a method to “grade” nonconformities resulting from an RA assessment of an AO, and to document the decision process for recognizing an AO or revoking recognition.