AO Assessment Program

The MDSAP includes the use of AOs, also known as Certification Bodies or Registrars in other schemes. An AO recognized to perform MDSAP audits must have demonstrated competence in each jurisdiction’s regulations. Therefore, the recognition is not restricted in terms of a RA’s jurisdiction and covers all jurisdictions participating in MDSAP. The letter of recognition to conduct medical device regulatory audits under MDSAP is standardized.

In accordance with best practices, the MDSAP incorporates a transparent assessment program by MDSAP RAs. This program includes a robust plan and schedule for assessing the competence and compliance of AOs with MDSAP requirements.

MDSAP RAs base their recognition and assessment process on IMDRF MDSAP Working Group and MDSAP documents, in addition to other documents approved by the MDSAP RAC.

In particular, MDSAP RAs will assess an AO’s compliance to the requirements of:

IMDRF MDSAP WG N3 Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition

IMDRF MDSAP WG N4 Competence and Training Requirements for Auditing Organizations

ISO17021 Conformity assessment – Requirements for bodies providing audit and certification of management systems

Relevant MDSAP policies and procedures.

When an AO meets all assessment program requirements, it is granted recognition by the MDSAP RAC.

Recognition of an AO means recognition by each MDSAP RA. A recognition decision under the MDSAP will not impact designations or authorities held in other jurisdictions.

It is important to note, RAs assess AOs, AOs audit manufacturers.

Further information on AO Assessments is also available under Frequently Asked Questions/Assessments.