MDSAP Fundamentals and Readiness Training
You will increase your knowledge of the guidelines for conducting MDSAP regulatory audits and the skills needed within your organization to know you are prepared and ready to host audit
Objective and outcome
This course is broken down into a combination of knowledge and skills. You will increase your knowledge of the guidelines for conducting MDSAP Regulatory audits and the skills needed within your organization to know you are prepared and ready to host the audit.
On completion, successful delegates should gain the displayed knowledge and skills:
- 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 for successfully hosting a MDSAP audit:
- MDSAP 7 auditing process requirements
- Plan audit scopes
- Analyze data sources required during process audits
- Analyze control interactions
- Use correct jurisdictional terminology
Who should attend
This course is designed for anyone from the medical device industry with responsibility for one or more elements of an organization’s quality management system, including staff and top management in regulatory compliance, QA/QC, and internal auditing.
Cédric Razaname, Project Associate, Medidee Services SA
"Very informative and interesting. The overall picture on how to approach the MDSAP became clearer"
"Good knowledge of the instructor and good discussions"
"The instructor had good presentation skills and asked good questions that triggered new ways of thinking or approaching the topic"
"Very informative and interesting"
Participants, Fall 2018