Medical Device Single Audit Program (MDSAP) – Requirements and Preparation

Course description

The Medical Device Single Audit Program (MDSAP) model was developed by the International Medical Device Regulators Forum (IMDRF). IMDRF’s goal for developing a single audit model was to promote greater alignment and flexible use of regulatory resources through work-sharing and mutual acceptance among regulators while respecting the sovereignty of each authority. The MDSAP allows a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple regulatory authorities. MDSAP audits can only be carried out by authorized auditing organizations.

International partners that are participating in the MDSAP include: Australia, Brazil, Canada, Japan, and USA.

In this course, you will discover the fundamentals of MDSAP and will learn to interpret the MDSAP audit approach correctly. You will gain an understanding of MDSAP Audit structure and core processes. In addition, you will discover how to apply and align MDSAP to the internal audit program.

Course Contents

• Introduction and general requirements 
• The MDSAP audit model 
• New aspects by the MDSAP audit approach:
  • Grading system of non-conformities (1-5)
  • Determine the audit duration with two tools (procedure, Excel workbook)
  • Country specific requirements
• Tips to prepare a MDSAP audit

Who Should Attend

This course is ideal for:

• Medical device manufacturers and exporters 
• Quality Management Professionals
• Regulatory Affairs Professionals
• External and internal auditors

Course Objectives

• Learn the basics of MDSAP — get an understanding of the concepts, audit structure and benefits of MDSAP.
• Understand the key requirements of MDSAP to facilitate the market access of your medical devices.
• Learn to prepare effectively a MDSAP audits and detect non-conformities more easily and quickly.

Requirements

No requirements are necessary.

Methodology

This seminar addresses internationally valid standards. This seminar could be chosen as single training but is also part of a modular qualification: “Manager Regulatory Affairs - TÜV” and “Manager Regulatory Affairs International - TÜV”.

After successful participation in the that modules, you could obtain the following recognized qualifications:

• Regulatory Affairs Manager – TÜV 
• International Regulatory Affairs Manager – TÜV 

Certificate

TÜV SÜD Academy certificate of attendance