Roles and Responsibilities

RA assessors  

To ensure a consistent approach to all assessments, MDSAP RA assessors are qualified against the requirements of IMDRF MDSAP WG N6, Regulatory Authority Assessor Competence and Training Requirements. They participate in both face to face and distance training activities. The program operates under a joint MDSAP QMS to establish controls and to facilitate continuous improvement. Applicable MDSAP Assessment Procedures and Forms are publicly available. Assessors usually perform assessments in teams in accordance with the assessment program.  

Assessment Program Manager (APM) 

There are several APMs, usually one from each member jurisdiction, who support the management of the MDSAP assessment program. The APM drafts the initial assessment program and future amendments. They interface with AOs regarding assessment activities and the upcoming assessment program and review assessment outcomes and propose recognition decisions to the Technical Review and Recognition Committee (TRRC). They ensure the assessment activities are planned and implemented, assign assessment team members to assessment activities, and review assessment outcomes. The full list of responsibilities of an APM is in MDSAP AS P0034. 

Technical Review and Recognition Committee (TRRC) 

The TRRC is made up of a chairperson, the MDSAP APM who is relevant to the AO under review, and one representative from each RA from the MDSAP Subject Matter Experts group. Committee members are to be independent of the assessments that are under review. The TRRC is not a decision-making authority, rather it makes recommendations to the MDSAP RAC for recognition and de-recognition of the AO. 

Lead Project Manager (LPM) 

The LPM is responsible for managing, monitoring, and reporting the progress of a project agreed to or assigned by the RAC. The LPM also designates the APM to manage the assessment process for an AO. 

In regard to AO applications, the LPM: 

  • decides when issues requiring clarification identified during the review of the application package can be addressed during Stage 1 or Stage 2 assessments  

  • liaises with the RAC when the application review process is put on hold, pending clarification from the candidate AO 

  • consults with the RAC, and seeks concurrence of RAC when the APM proposes to reject the application package 

  • assists in the preparation official communication with the candidate AO to be issued by RAC Secretariat 

  • signs all communication to the candidate AO 

  • disseminates AO approval / rejection information to the participating MDSAP RAs.