This course will prepare you 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 mode for the jurisdictions where your products are marketed.
How will I benefit?
- Improve auditing skills focused on regulatory auditing
- Improve competence for MDSAP internal auditors and the support needed to host a MDSAP audit
- Assess your own audit models and suggest improvement
- Be prepared to support an efficient MDSAP audit by your selected Auditing Organization
- Receive a globally recognized certificate
Who should attend?
Quality Assurance and Regulatory Affairs professionals within medical device organizations currently active in participating territories and organizations expanding their market reach to jurisdictions participating in MDSA
What will I learn?
- Demonstrate awareness of MDSAP fundamentals
- Explain the structure and scope of the MDSAP audit program
- Explain the differences between MDSAP and other QMS audits
- Prepare to host a successful MDSAP audit
What is included?
- Detailed training course notes
- A loan copy of the standard, for use during the course
- Internationally recognized BSI Training Academy certificate
Prior knowledge and learning
Delegates will benefit from reviewing the MDSAP Companion Document and ISO 13485:2016 standard before attending this course.
