Medical Device Single Audit Program Implementation
This two-day Medical Device Single Audit Program (MDSAP) is for medical device manufacturers who want to be audited only once for compliance with the standard and regulatory requirements of multiple regulatory authorities.
The MDSAP course provides management system practitioners with the knowledge and skills required to implement a Quality Management System (QMS) which meets the regulatory requirements of multiple medical device markets.
You need this course if ...
- Your organization wants to maintain the effectiveness of its QMS compliance based on ISO 13485:2016 whilst adopting the relevant jurisdiction requirements in the countries engaged in the MDSAP
- You would like to learn how MDSAP differs from the traditional ISO 13485:2016 audit, through its regulatory audit approach, the grading of nonconformities and handling of the audit report
- Your organization wants to prepare for an upcoming audit ahead of the deadline.
You will learn …
- What is the Medical Device Single Audit Program (MDSAP) and why it was developed
- What regulatory authorities participate in the MDSAP program
- The fundamentals behind the MDSAP Audit model and companion guidance
- The structure and scope of the MDSAP audit program, audit processes and their interrelationships
- The differences between MDSAP and other QMS audits, to enhance your existing auditing skills and get prepared to support an efficient MDSAP audit
- How to identify MDSAP documentation and use correct jurisdictional terminology including reporting and nonconformity grading
- To prepare for the MDSAP audit time and use of the audit reports.
You will need …
- Ideally to possess some knowledge of QMS fundamentals prior to attending this MDSAP Implementation course.