Learn the key differences between MDSAP and ISO 13485
& how to prepare for an MDSAP Audit.
Learn the requirements of MDSAP, what gets audited and how to prepare for an MDSAP audit. This training (conducted as a workshop) is designed for staff in quality and regulatory functions in medical device, and combo-device companies. Learn in this 2-day MDSAP Audit Essentials training:
- What MDSAP Certification is about and when to consider it vs. ISO 13485
- Key differences between MDSAP and ISO 13485
- What gets audited in an MDSAP audit, the expected duration
- How to prepare for an MDSAP audit
- The Key Processes and Elements within the same that auditors will examine
The workshop is conducted in a highly interactive approach with exercises and quizzes that enable the participants grasp the important topics. Because of our independence, participants can bring their SOPs and other documents for review with the workshop leader, thereby ensuring that the learnings can be applied to your work processes immediately. The instructor will work to answer your questions as best as possible.
This two-day agenda is provided as a guide. Sequence of topics may vary to suit the audience.
Day 1
Day 2
Attendees successfully completing the training provided receive a Certificate of Participation, which includes the number of training hours attended