How to Successfully Prepare for Your MDSAP Audit
MDSAP outlines a standardized approach to regulatory quality management audits. Australia, Brazil, Canada, Japan and the United States are participating in the program. The initiative was launched as part of a global effort to accelerate the harmonization of various regulations governing the marketing of medical devices. This allows the relevant quality management requirements of multiple countries to be assessed simultaneously through a single audit.
However, preparing for such an audit is very time-consuming and costly. For many companies, the audit program therefore poses a major challenge.
This interactive seminar not only provides you with insight into the planning and process of MDSAP audits, but also offers useful tips on how to efficiently implement the requirements within your company.
- Content
- Fundamentals of the MDSAP Audit Program
- Origin, Purpose, and Benefits of the MDSAP Audit Program
- MDSAP Organization and Regulatory Authorities
- The MDSAP Audit Model
- Overview of the Seven MDSAP Audit Processes
- Scope of the MDSAP Audit
- MDSAP Non-Conformity (NC) Assessment Scheme
- Audit Duration Calculation
- MDSAP Documents
- Publicly Available MDSAP Documents
- The Seven MDSAP Processes
- Process 1: Management
- Process 2: Measurement, Analysis, and Improvement
- Process 3: Medical Device Adverse Events and Advisory Notice Reporting
- Process 4: Design and Development
- Process 5: Device Marketing Authorization and Facility Registration
- Process 6: Production and Service Controls
- Process 7: Purchasing
- Selection of Country-Specific Additional Requirements for Each Process
- Your Benefits
- You will learn how to streamline market access using the MDSAP program.
- You will understand the requirements of the MDSAP program.
- You will receive useful tips on how to effectively prepare for an MDSAP audit.
- You will be able to identify nonconformities in your quality management system.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Manufacturers of medical devices and in vitro diagnostic devices
- Regulatory affairs staff
- Quality management representatives
- Quality management team members
- Internal and external auditors
- Management
