This two-day Medical Device Single Audit Program (MDSAP) Implementation course is for medical device manufacturers who want to be audited only once for compliance with the standard and regulatory requirements of multiple regulatory authorities.
This course provides management system practitioners with the knowledge and skills required to implement an ISO 13485:2016 Quality Management System (QMS) which meets the regulatory requirements of different medical device markets: Australia, Brazil, Canada, Japan and the United States.
You can choose between our MDSAP Implementation public course or an in-house event. Our public courses allow delegates to interact and network with other delegates from various medical device companies and appreciate how other organisations have interpreted and implemented MDSAP. As an in-company event, our experts come to you and the training course can be tailored to your organisation’s own management system and run at a date and time to suit you.
Who should attend?
This implementation course is relevant to professionals involved with an ISO 13485:2016 management system, plan to continue placing devices on the market in Australia, Brazil, Canada, Japan and the United States and:
- Your organisation 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 organisation wants to prepare for an upcoming audit ahead of the deadline.
This training course is designed for those who already possess some knowledge of QMS fundamentals prior to attending this MDSAP Implementation course.
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, enhancing your existing auditing skills and be 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.
What do I need to prepare for this course?
Ideally you will have knowledge of ISO 13485:2016 and/or EN ISO 13485:2016 fundamentals
- ISO 13485:2016 Appreciation and Interpretation
- ISO 13485:2016 Implementation
- ISO 13485:2016 Internal Auditor.
Recommended group size:
4 to 12 delegates with one trainer.
Dates and Locations