IA-SMQ-09 1 day (7h) · Virtual classroom

MDSAP — Decoding the audit model and preparing your QMS to undergo a single international audit

Exporting to Canada, the United States, Brazil, Australia or Japan? MDSAP is no longer an option: it has been mandatory for the Canadian market since 2019 and an accelerator for access to the four other markets. But an MDSAP audit does not resemble an ISO 13485 audit: a fixed sequence of processes, four-level grading of nonconformities, a report sent directly to national regulatory authorities. Poorly prepared, it is costly. Well prepared, it opens five markets simultaneously in a single cycle. This virtual classroom day equips QA, RA teams and internal audit managers with the structural understanding and practical tools to confidently approach an MDSAP audit, from the auditee's side.

Audience Quality Assurance (QA) managers and officers, regulatory affairs (RA) managers and officers, internal audit managers and QMS coordinators in medical device manufacturing companies targeting or already engaged in an MDSAP program (Canada, United States, Brazil, Australia, Japan markets).

Learning objectives

  • ▸ Explain the origin, objectives and governance of the MDSAP program: the role of the IMDRF, of the five participating regulatory authorities and of the Auditing Organizations (AO).
  • ▸ Describe the structure of the MDSAP audit model: the 7 audit processes, their mandatory sequence, their interactions and the associated tasks.
  • ▸ Distinguish the specific requirements of each jurisdiction (Canada/Health Canada, United States/FDA 21 CFR Part 820/QMSR, Brazil/ANVISA, Australia/TGA, Japan/MHLW) layered onto the ISO 13485 base.
  • ▸ Interpret the MDSAP nonconformity grading system (grades 1 to 5) and its regulatory consequences for each participating jurisdiction.
  • ▸ Identify, process by process, the deviations most frequently raised during MDSAP audits and the expected documented evidence.
  • ▸ Build an MDSAP audit preparation plan: gap analysis, key documents to prepare per process, front office / back office organization, team preparation.
  • ▸ Formulate a response to MDSAP nonconformities compliant with AO expectations: deadlines, required level of root cause analysis, evidence of effectiveness.

Expected outcomes

  • ✓ ISOFACADEMY MDSAP gap analysis grid by process, applied to the participant's QMS by the end of the day.
  • ✓ Visual map of the 7 MDSAP processes and comparative table of the 5 jurisdictions layered onto ISO 13485.
  • ✓ Audit preparation guide (front/back office organization, key documents, NC response schedule) directly applicable.

Accessibility & entry conditions

Access lead time

Registration up to 10 working days before the start of an open-enrolment session. In-house sessions can be scheduled within 3 to 4 weeks.

Prerequisites

Solid knowledge of the ISO 13485 standard and of a medical device QMS environment. It is strongly recommended to have read the MDSAP Companion Document (available free of charge on the FDA/IMDRF website) before the session — a download link is sent upon registration. The course is not an introduction to ISO 13485: the basics are assumed to be acquired.

Disability access

Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →

Funding

  • ·OPCO (all sectors)
  • ·Skills development plan
  • ·CPF (subject to the course being listed)
  • ·Company self-funding

Detailed programme

A phone interview or positioning questionnaire is sent ahead of the session to calibrate the level, identify expectations and tailor the case studies to participants' real situations.

  1. 01

    Origin, governance and strategic stakes of MDSAP (45 min)

    • ·Why MDSAP? IMDRF context, proliferation of multi-market audits, objective of global regulatory harmonization
    • ·Five participating jurisdictions: Health Canada, FDA (United States), ANVISA (Brazil), TGA (Australia), MHLW (Japan) — scopes, obligations, status of MDSAP
    • ·Mandatory vs voluntary: Canada (mandatory classes II/III/IV since 2019), other markets (voluntary but recognized)
    • ·Recognized Auditing Organizations (AO): who can perform an MDSAP audit, how to choose your AO, role of GMED, BSI, TÜV and others
    • ·MDSAP certification cycle: initial audit, annual surveillance audits (S1/S2), recertification audit at 3 years
    • ·MDSAP and MDR 2017/745 articulation: can the two be combined? What the two frameworks share and what distinguishes them
    • ·Entry quiz on participating countries, obligations and key stakeholders
  2. 02

    The MDSAP audit model: structure, sequence and processes (1h30)

    • ·Logic of the audit model: an audit based on processes, not on standard clauses
    • ·Process 1: Management
    • ·Process 2: Facility registration and marketing authorization
    • ·Process 3: Measurement, analysis and improvement
    • ·Process 4: Design and development
    • ·Process 5: Production and service controls
    • ·Process 6: Purchasing
    • ·Process 7: Facilities, machinery and equipment
    • ·Tasks: structure of the Companion Document, task numbering, link between task and regulatory requirement
    • ·Links and interactions between processes: why the sequence is non-modifiable and how it structures the audit week
    • ·Visual map of the 7 processes and their interactions, handed out to participants
  3. 03

    Specific requirements of the 5 jurisdictions layered onto ISO 13485 (1h)

    • ·Common base: ISO 13485:2016 as the universal foundation of MDSAP
    • ·FDA / 21 CFR Part 820 (QMSR since 2026): key points of divergence with ISO 13485
    • ·Health Canada: establishment registration, reporting obligations
    • ·ANVISA (Brazil): product registration, specific GMP requirements
    • ·TGA (Australia): requirements for Australian sponsors, supplementary technical documentation
    • ·MHLW (Japan): JGMP, specific requirements on change management
    • ·Notion of "regulatory links" in the Companion Document: identifying which task covers which requirement for which country
    • ·Comparative table of the 5 jurisdictions across the 7 processes, handed out to participants
  4. 04

    Grading of MDSAP nonconformities and consequences (1h)

    • ·5-level grading system: Grade 1 (observation), Grade 2 (minor), Grade 3 (major), Grade 4 (critical), Grade 5 (critical with immediate danger)
    • ·Grading criteria: impact on patient safety, recurrence, systemic nature, geographic extent
    • ·Consequences of grading by jurisdiction: imposed response deadlines, notification to authorities, possible suspension of the certificate
    • ·Fundamental differences with the classic ISO 13485 nonconformity system: why teams accustomed to ISO 13485 are often surprised
    • ·Handling an MDSAP NC: response deadlines, required level of root cause analysis depending on the grade, expected evidence of effectiveness
    • ·Grading exercise on 5 fictitious nonconformity cases with commented correction
  5. 05

    Preparing your QMS to undergo an MDSAP audit (1h30)

    • ·MDSAP gap analysis: assessing the gap between the existing ISO 13485 QMS and MDSAP requirements by process
    • ·Key documents to prepare for each process: lists of expected evidence process by process
    • ·Front office / back office organization: who responds to the auditor, who searches for the evidence, who handles coordination
    • ·Preparing non-QA teams (production, R&D, purchasing) to be audited: key messages to convey to them
    • ·Time management during the audit: an MDSAP audit lasts several days — how to optimize the schedule and anticipate requests
    • ·Most frequent mistakes on the auditee's side during a first MDSAP audit
    • ·MDSAP gap analysis grid by process, handed out to participants
  6. 06

    Responding to post-audit nonconformities and steering the follow-up (45 min)

    • ·Structure of a formal response to an MDSAP NC: immediate correction, root cause analysis, corrective action, effectiveness verification plan
    • ·Deadlines imposed by grade and by jurisdiction: calendar days vs business days, the pitfalls to avoid
    • ·Post-audit follow-up: how the AO verifies the effectiveness of CAPA, interaction with national regulatory authorities
    • ·Handling several simultaneous nonconformities: prioritization, communication with the AO
    • ·Open Q&A and summary of the day

Assessment of learning

Assessment methods

Entry quiz (Module 1) · commented grading exercise (Module 4) · gap analysis self-assessment on the 7 processes (Module 5) · final 20-question multiple-choice test (QCM) (program structure, 7 processes, 5 jurisdictions, grading, audit preparation — pass threshold: 60%) · Individual deliverable: MDSAP gap analysis grid applied to the participant's QMS and identification of their 3 preparation priorities. Training certificate issued subject to full participation in the day. This certificate does not constitute an RNCP/RS certification, nor an MDSAP auditor qualification.

Certificate

A certificate of completion is issued to each participant, detailing the objectives, duration, learning assessed and the result of the final assessment. The document can be kept in a skills record.

Satisfaction and results

Satisfaction rate: Being measured

First learner survey campaign under way — data published once the statistical threshold is reached.

Training team

Training delivered by the ISOFAC ACADEMY teaching team, made up of consultants specialised in medical devices, quality and regulatory affairs. Depending on the module, the session is led by a specialist with hands-on operational expertise in MDR compliance, ISO 13485 quality management systems, ISO 14971 risk management, clinical evaluation, technical documentation, regulatory audits and CE marking strategy.

Our trainers support manufacturers, distributors, importers, authorised representatives and other economic operators on a daily basis in bringing their medical devices into compliance. See the team's profiles →

Technical resources

In-person

Room equipped at the client site or in a partner centre (Montpellier, Lyon, Paris). Video projector, flipchart, printed materials.

Remote

Zoom (corporate) platform for the virtual classroom. Materials provided in PDF + access to additional resources for 12 months after the session.

Learner equipment

A connected computer with camera and microphone for remote sessions. No software to install.

Post-course follow-up

Advice line

Hotline included for 30 days after the session for operational questions arising back on the job. Reply within 48 working hours.

Follow-up review

3-month review sent to the sponsor for in-house courses: feedback on the skills put into practice and any residual points.

Open-enrolment price (excl. VAT)

890 €

EU VAT applicable depending on the buyer's status.

In-house price

On request, depending on headcount and location.

Funding

  • ·OPCO (all sectors)
  • ·Skills development plan
  • ·CPF (subject to the course being listed)
  • ·Company self-funding

Personalised quote and OPCO funding application prepared within 48 hours.

Would you like to attend this course?

Tell us your preferred format (open-enrolment, in-house or virtual classroom), the number of participants and your schedule. We will get back to you within 48 hours with the next available dates and a firm quote.

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