QMSR in the United States
Since 2 February 2026, 21 CFR 820 incorporates ISO 13485:2016 by reference. US-specific requirements moved to other parts of the CFR.
MDSAP Solutions
MDSAP Lead Auditor, Excellence & Strategic Leadership
42-hour training updated for the 2026 MDSAP AU P0002.011, with Exemplar Global certification.
November cohorts, live online. Full-time over 5 days or evening sessions of 3h30.
Exemplar Global certification
MDSAP Training
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MDSAP lead auditor training and training for internal audit teams.
42hLead Auditor
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Exemplar Global
Exemplar Global
MDSAP Lead Auditor, Excellence & Strategic Leadership
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42 hours, live online
Industry professionals and consultants
MDSAP 2026
Technical foundation: MDSAP AU P0002.011
Exemplar Global certification
42 hours, live online
MDSAP 2026
Technical foundation: MDSAP AU P0002.011
Exemplar Global certification
42 hours, live online
Corporate Training
MDSAP Internal Auditor
Explore the course
Enquire about duration, format and dates
Industry Quality Management teams
Internal auditing
ISO 13485:2016
MDSAP Audit Approach
Enquire about duration, format and dates
Internal auditing
ISO 13485:2016
MDSAP Audit Approach
Enquire about duration, format and dates
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What changed in MDSAP 2026
If your last MDSAP training was before 2026, the benchmark has changed. See what has been added to the programme and course.
Technical foundation: MDSAP AU P0002.011, revision dated 3 August 2026, and the current legislation of the five jurisdictions. QMSR 21 CFR 820 and ISO 13485:2016.
Recalls in Canada
Initial information must now be provided in writing within 24 hours of the decision, with a final report within 30 days.
Cybersecurity
Section 524B entered the audit scope: a cybersecurity plan, update processes and an SBOM in the software design file.
Reporting deadlines
A supplementary report in the USA within 30 calendar days. The 5-day report is counted in business days.
Current legislation takes precedence over the document
Where the programme document differs from the regulation in force, the auditor cites the regulation. The course teaches both readings and which takes precedence.
Why HSC?
HSC Global Group is a Recognized Training Provider (RTP) recognised by Exemplar Global, with international certification for learners.
While updating the material for the 2026 revision, we identified an inconsistency in the official programme document and consulted CDRH in writing. FDA confirmed HSC's interpretation and stated that the correction will be included in the next revision. This is the rigour learners bring to their own audits.
All material cites the regulatory source for each statement, checked against each country's official text.
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.
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
Live online MDSAP course, November cohorts
Full-time cohort
9 to 13 November 2026, 08:30 to 17:30
Evening cohort
17 November 2026 to 26 January 2027, 19:00 to 22:30
12 places per cohort. Enrolment closes on 6 November 2026. Dates are subject to change. Cohort confirmation up to 5 days before the start.
Instructor: Mariana Barreira, MDSAP lead auditor.
- Recordings available for 120 days after completion.
- Learning materials available for 1 year.
- Minimum attendance of 75% and a minimum mark of 70% for certification.
- Cancellation with a full refund within 7 days of purchase, under Article 49 of the Brazilian Consumer Protection Code.
- Materials included in the course fee: workbooks, standards and exercises.
MDSAP Internal Auditor
Does your team conduct internal audits? Explore the MDSAP Internal Auditor course, covering ISO 13485:2016, the MDSAP Audit Approach and the changes in ISO 19011:2026.
Explore MDSAP Internal AuditorFive jurisdictions in the MDSAP programme
Our MDSAP training prepares you for audits in the world's leading regulatory markets.
Global reach
MDSAP extends beyond the 5 member countries
The programme has three types of participation: Regulatory Authority Council (RAC) members, official observers and affiliate members. Use of MDSAP reports and certificates follows each authority's scope and requirements; certification does not automatically authorise products to be marketed.
Full members
The decision-making council (RAC), comprising five participating authorities.
BrazilANVISA
United StatesFDA
CanadaHealth Canada
JapanMHLW/PMDA
AustraliaTGA
Official observers
They follow and contribute to the programme without being full members.
European UnionEuropean CommissionUnited KingdomMHRA
SingaporeHSA
WHOIVD prequalification
Affiliate members
They recognise and use the report and/or certificate, without voting rights.
ArgentinaANMAT
MexicoCOFEPRIS
South KoreaMFDS
TaiwanTFDA
IsraelMinistry of Health
MalaysiaMDA
South AfricaSAHPRA
KenyaPPBTanzaniaTMDA
Source: official MDSAP participation, checked on 5 October 2026. The list of participants may change; use of reports and certificates depends on each authority's regulatory framework.
Frequently asked questions
How does the course work?
Live online, with recorded Module 1 as a prerequisite for joining the sessions. Class recordings remain available for 120 days after completion to support enrolled learners.
Which cohorts are planned?
Full-time: 9 to 13 November 2026, 08:30 to 17:30. Evening: 17 November 2026 to 26 January 2027, 19:00 to 22:30. Dates are subject to change. Cohort confirmation up to 5 days before the start.
What are the certificate requirements?
Minimum attendance of 75% and a minimum mark of 70%. HSC is a Recognized Training Provider (RTP) recognised by Exemplar Global.
How do I request enrolment?
On the Lead Auditor course page or in the Online Store, click Register, choose the cohort and enter your details in the modal. The HSC Global team will contact you to continue the enrolment process.
Is there training for internal auditing?
Does your team conduct internal audits? Explore the MDSAP Internal Auditor course, covering ISO 13485:2016, the MDSAP Audit Approach and the changes in ISO 19011:2026.
November cohorts with 12 places. Enrolment closes on 6 November 2026.
Dates are subject to change. Cohort confirmation up to 5 days before the start.
