Understanding the Requirements of the International MDSAP Audit Approach

Overview:

The topic of the webinar will cover Medical Device Single Audit Program (MDSAP) approach, evaluation of MDSAP approach towards the Quality Management System (QMS), audit nonconformity grading system and recognition of grades that may trigger regulatory follow-up

Why you should Attend:

This webinar covers the rationale for developing the Medical Device Single Audit Program (MDSAP), who the participating regulatory authorities are, and the specific audit criteria (including country-specific requirements) used during MDSAP audits. The audit approach used by recognized MDSAP auditing organizations (AOs) as well as the MDSAP nonconformity grading system will be presented. 

Areas Covered in the Session:

• What is MDSAP 
• MDSAP Benefits 
• Regulatory Authorities Usage of MDSAP 
• How MDSAP Works? 
• Medical Device Manufacturers Audit Criteria and Cycle 
• Auditing Organization Assessments
• Current Status of the MDSAP Program 

Who Will Benefit:

• Medical Device : Manufacturing Engineer, Quality Engineer, validation specialist/manager, Quality Manager with intermediate level experience in manufacturing, engineering, validation, quality control and assurance 
• Auditors and Lead auditors