About MDSAP - MEDICAL DEVICE SINGLE AUDIT PROGRAM
Why this course:
This course pack is designed to give you a detailed understanding of the medical device single audit program. After the training you will have a good knowledge of the MDSAP regulatory requirements, skills to implement the requirements within your organisation and an increased readiness to host a MDSAP audit.
Who can attend this course:
- Quality Managers
- Regulatory Affairs personnel
- Internal Auditors
For successful completion of this course, it is expected that you have prior knowledge of ISO 13485:2016 standard.
It is also recommended to have prior knowledge of the Regulatory Registration with the following countries:
- FDA – US
- ANVISA – Brazil
- HC – Canada
- TGA – Australia
- PMDA – Japan
The training is in English.
- An overview of the MDSAP
- Focus on key Processes
- How to use the MDSAP Audit Model and its tools
At the end of this training session, you will have a very good understanding of:
- The requirements as stated in the MDSAP and
- The benefits of enrolling into the MDSAP Program
The training is held as online training.