Introduction to MDSAP
The Medical Device Single Audit Plan is beyond the pilot program phase and is starting up to replace the normal audit structure. Countries which embrace MDSAP are Australia, Brazil, Canada, Japan and the United States of America. Canada has already announced that as of January 1st, 2019 only audit results according to MDSAP are accepted for regulatory compliance and submissions. It can be expected that other associated Regulatory Authorities will do the same in due time. Audit Organisations also start preparing and implementing the Medical Device Single Audit Plan. So you should do the same.
During the course, you will obtain the knowledge to understand MDSAP and the possible impact on your organization. What are the fundamentals of MDSAP, how are audits performed and what do you need to do to prepare your own organization.
Who should attend?
This training is meant for management, QA and RA managers, internal audit coordinators, internal auditors and others involved in internal and external audits.
A specific entry level is not required. The requirements are based on ISO 13485, so a basic understanding and knowledge of the standard are beneficial.
We offer open enrolment, on-location, train-the-trainer formats and webinars.
Please contact us at firstname.lastname@example.org to schedule in-house training, which is also recommended for training multiple colleagues or teams at the same time.