How to Prepare Successfully for Your MDSAP Audit
Two-Day Applied Course
The Medical Device Single Audit Program (MDSAP) defines a harmonized approach to regulatory quality management system (QMS) audits. The program is recognized by Australia, Brazil, Canada, Japan, and the United States.
MDSAP was developed as part of a global initiative to accelerate the harmonization of regulatory requirements for medical device market authorization. Through a single audit, the quality management system requirements of multiple regulatory authorities can be assessed simultaneously.
However, preparation for an MDSAP audit can be complex, time-consuming, and resource-intensive, posing a major challenge for many manufacturers.
In this interactive seminar, you will gain insight into the structure, planning, and execution of MDSAP audits and receive practical guidance on how to efficiently implement the program’s requirements within your organization.
- Content
- Fundamentals of the MDSAP Audit Program
- Origin, purpose, and benefits of the MDSAP framework
- MDSAP organization and participating regulatory authorities
- The MDSAP Audit Model
- Overview of the seven MDSAP audit processes
- Scope and audit coverage
- MDSAP Nonconformity Grading System (NC Grading Schema)
- Audit duration calculation
- MDSAP Documentation
- Overview of publicly available MDSAP documents
- The Seven MDSAP Processes
- Management
- Measurement, Analysis, and Improvement
- Medical Device Adverse Events and Advisory Notice Reporting
- Design and Development
- Device Marketing Authorization and Facility Registration
- Production and Service Controls
- Purchasing
- Inclusion of country-specific additional requirements for each process
- Fundamentals of the MDSAP Audit Program
- Your Benefits
- Learn how to leverage MDSAP to streamline international market access.
- Understand the requirements and structure of the MDSAP framework.
- Receive practical tips and tools to prepare effectively for an MDSAP audit.
- Gain the ability to identify and address nonconformities in your QMS before the audit.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Manufacturers of medical devices and in vitro diagnostic devices
- Regulatory Affairs professionals
- Quality Management Representatives (QMRs)
- Quality Management team members
- Internal and external auditors
- Executive management
