Medical Device Single Audit Program (MDSAP): Fundamentals and Readiness
This two day course will help you to prepare to host a MDSAP audit and allow you to determine if your own internal QMS processes are consistent with the requirements of the MDSAP audit model for the jurisdictions where your products are marketed. On completion of the training, delegates will be able to support their organization to maintain compliance to ISO 13485 and jurisdiction requirements in the countries engaged in the MDSAP program.
Who should attend?
- Quality Assurance and Regulatory Affairs professionals within medical device organizations who need to transition their CMDCAS certifications and organizations expanding their market reach to jurisdictions participating in MDSAP.
What will I learn?
On completion of this training, delegates will have the:
- Demonstrate awareness of MDSAP fundamentals
- Explain the structure and scope of the MDSAP audit program:
- MDSAP audit processes and their interrelationships
- MDSAP and organizational regulatory compliance
- MDSAP reporting and nonconformity grading
- Explain the differences between MDSAP and other QMS audits
- MDSAP and auditing in the medical device industry
- ISO 13485 and ISO 14971
- Identify MDSAP documentation
Prepare to host a successful MDSAP audit:
- MDSAP 7 auditing process requirements
- Plan audit scopes
- Analyze data sources required during process audits
- Analyze control interactions
- Use correct jurisdictional terminology
- Trainging course notes