Full-time
5 daystoNovember 2026
08:30 to 17:30
12 places per cohort, with enrolment open until 6 November 2026.
MDSAP Lead Auditor, Excellence & Strategic Leadership
About the course
42-hour training updated for the 2026 MDSAP AU P0002.011, with Exemplar Global certification.
Technical basis: MDSAP AU P0002.011, revision dated 03/08/2026, and current legislation in the five jurisdictions.
November 2026 cohorts
Evening
3h30 sessionsto
19:00 to 22:30
Dates are subject to change, with cohort confirmation up to 5 days before the start.
Course programme
The lead auditor mindset. Recorded, a prerequisite for joining the sessions
The Audit Approach task by task, through ISO 13485:2016
Requirements by jurisdiction: Brazil, United States, Canada, Australia and Japan
Nonconformity grading and audit reporting
Audit planning, sampling and execution
Audit simulation and final assessment
Who is this for?
Lead and internal auditors who conduct or wish to conduct MDSAP audits.
Regulatory affairs and quality management system consultants.
Quality managers and coordinators at manufacturers that export or intend to export.
Professionals who will lead the certification audit within their own company.
Your instructor
Mariana Barreira
Exemplar Global-certified MDSAP Lead Auditor
More than 10 years' experience implementing ISO 13485 QMS and working across the programme's 5 countries.
Certification
HSC Global Certificate Recognised by Exemplar Global RTP
Course information
120 days
To watch the lessons again
Recordings available after the course ends.
1 year
Of access to materials
Teaching materials available for reference.
75% minimum attendance
Minimum pass mark of 70%
What is included
Course handbooks, standards and exercises included in the fee.
What changed in MDSAP 2026Cancellation policy
Cancellation with a full refund within 7 days of purchase, under Article 49 of the Brazilian Consumer Protection Code.