Description

A focused course, tailored for you

Building the Modern Medical Device Quality and Compliance Practice (ISO 13485 + EU MDR/IVDR + FDA QSR + Risk + AI/SaMD + Post-Market)

Build the modern medical device quality and compliance practice in 10 weeks. ISO 13485 + EU MDR/IVDR + FDA QSR + risk + AI/SaMD + post-market.

Medical device quality and compliance practice has shifted: EU MDR/IVDR transition, FDA QSR alignment to ISO 13485 (effective February 2026), AI/SaMD regulatory framework, post-market surveillance modernisation, and EUDAMED operational expectations. Quality consultants who build the modern practice take the senior client work. Here is the 10-week build.

$199 one-time

Tailored to your situation. Access within 24 hours. 30-day money-back.

Includes a hand-built implementation playbook delivered alongside course access, generated for your specific situation.

Why this course

Medical device quality and compliance practice (consultants serving small and mid-cap device makers, in-vitro diagnostics manufacturers, AI-medical-device firms, digital-health firms, contract manufacturers) has shifted in 2024-2026.

EU MDR transition (devices on the market under MDD facing transition deadlines through December 2027), EU IVDR transition (extended deadlines through 2027/2029), FDA Quality System Regulation harmonisation to ISO 13485:2016 (final rule effective February 2026), AI/SaMD (Software as Medical Device) regulatory framework (FDA AI/ML SaMD Action Plan, FDA PCCP guidance, EU AI Act as medical device, IMDRF), post-market surveillance modernisation (PMS plan, PMCF, PMPF, vigilance), EUDAMED operational expectations (modules in production roll-out), and cybersecurity overlay (FDA Section 524B, EU MDR Annex I requirements, IEC 62443, NIS2) all need to land at the quality practice.

Quality consultants who build the modern practice take the senior client work. Consultants who stay on classic QMS-only patterns watch the senior work shift to peers.

This course teaches the 10-week build of the modern medical device quality and compliance practice: ISO 13485 + FDA QSR alignment, EU MDR/IVDR framework, AI/SaMD regulatory framework, risk management framework (ISO 14971 + IEC 62366), post-market surveillance, cybersecurity overlay, and the engagement model. Twelve modules with deliverables. Plus a hand-built implementation playbook for your specific client mix.

What you walk away with

A documented ISO 13485 + FDA QSR alignment framework.
An EU MDR/IVDR transition framework.
An AI/SaMD regulatory framework.
A risk management framework (ISO 14971 + IEC 62366).
A post-market surveillance framework.
A cybersecurity overlay (FDA 524B + EU MDR + IEC 62443 + NIS2).
An engagement model.
A 10-week build plan.

The 12 modules

Module 1. Medical device compliance landscape 2026

Detailed walkthrough of the medical device compliance landscape in 2026: FDA QSR final rule (effective February 2026 aligning to ISO 13485:2016), EU MDR transition timelines (extended through 2027), EU IVDR transition timelines (extended through 2027/2029), FDA AI/ML SaMD Action Plan + PCCP guidance, EU AI Act application to AI medical devices (high-risk Annex III classification), IMDRF guidance, cybersecurity FDA Section 524B + EU MDR Annex I, EUDAMED roll-out, and the strategic-level decisions facing quality consultants and quality leaders.

Module 2. ISO 13485 + FDA QSR alignment

Build the ISO 13485 + FDA QSR alignment framework: gap-analysis framework, transition pathway, internal-audit programme alignment, management-review pattern, document-control system, training and competency programme, supplier-management programme, and the integration with broader QMS. The framework that handles the February 2026 transition.

Module 3. EU MDR/IVDR transition

Build the EU MDR/IVDR transition framework: device-classification mapping (current vs MDR/IVDR), notified-body engagement model, technical-documentation framework (Annex II), clinical-evaluation framework (MDCG guidance, ISO 14155, IEC 62366), clinical-investigation framework where applicable, post-market clinical follow-up (PMCF), unique-device-identification (UDI), and the EUDAMED registration framework. Three transition patterns at peer device makers.

Module 4. AI/SaMD regulatory framework

Build the AI/SaMD regulatory framework: FDA SaMD classification, FDA AI/ML SaMD Action Plan integration, FDA Predetermined Change Control Plan (PCCP) framework, EU AI Act high-risk classification overlay, IMDRF SaMD framework, model-lifecycle management framework (training, validation, deployment, monitoring, retraining), algorithm-locked vs adaptive-AI framework, and the post-market AI monitoring framework. Three SaMD patterns at peer AI device firms.

Module 5. Risk management framework

Build the risk management framework: ISO 14971:2019 risk-management process integration, hazard-analysis framework, risk-control measure framework, residual-risk-acceptability framework, post-production risk-management feedback, usability-engineering integration (IEC 62366-1), human-factors integration (FDA guidance), and the integration with broader QMS. The framework that wins notified-body review and FDA review.

Module 6. Post-market surveillance framework

Build the post-market surveillance (PMS) framework: PMS plan, PMS report (PSUR), PMCF plan and PMCF report, PMPF (for IVDs), vigilance reporting (MDR, FSCA, FSN), trend reporting, complaint-handling integration, and the integration with broader PMS. The framework that satisfies EU MDR/IVDR + FDA vigilance + IMDRF.

Module 7. Cybersecurity overlay

Build the cybersecurity overlay: FDA Section 524B (Cybersecurity in Medical Devices) requirements, FDA cybersecurity premarket guidance (September 2023), FDA cybersecurity postmarket guidance, EU MDR Annex I cybersecurity requirements (essential principles), IEC 62443 IACS cybersecurity application, IEC 81001-5-1 health software cybersecurity, EU NIS2 critical-infrastructure overlap (where applicable), SBOM requirements, vulnerability disclosure framework, and the integration with broader product security.

Module 8. Technical documentation framework

Build the technical documentation framework: design-history file (DHF) under FDA QSR/ISO 13485, technical-documentation under EU MDR Annex II, technical-documentation under EU IVDR, design-controls framework, design-verification and validation framework, design-transfer framework, design-changes framework, and the integration with broader product lifecycle management (PLM).

Module 9. Notified-body and FDA engagement

Build the notified-body and FDA engagement framework: notified-body selection (BSI, TÜV SÜD, DEKRA, Intertek, MDC, Eurofins), FDA Q-Sub programme, FDA 510(k) pathway, FDA De Novo pathway, FDA PMA pathway, FDA breakthrough device designation, MDUFA timelines, EU CE-marking conformity-assessment pathways (Annex IX, X, XI), and the integration with broader regulatory affairs.

Module 10. Engagement economics

Build the engagement economics framework: fixed-price vs T&M vs retainer pricing model selection, project-based vs ongoing-advisory model, sub-contractor and sub-consultant model, project-margin computation, and the practice-economics framework. The framework that protects margin in independent quality consulting.

Module 11. Practice positioning

Build the practice positioning: positioning statement, demo (showing ISO 13485 + FDA QSR alignment, EU MDR/IVDR transition, AI/SaMD framework), ROI calculator (audit readiness improvement, time-to-market reduction, vigilance-event reduction), case studies (3 minimum), and the discovery-conversation guide. Sales materials that win the next med-device quality engagement.

Module 12. Your 10-week build plan

Week-by-week plan with weekly deliverables. Weeks 1-2: medical device compliance landscape + ISO 13485 + FDA QSR alignment framework. Weeks 3-4: EU MDR/IVDR transition framework + AI/SaMD regulatory framework. Weeks 5-6: risk management framework + post-market surveillance framework. Weeks 7-8: cybersecurity overlay + technical documentation framework. Weeks 9-10: notified-body and FDA engagement + engagement economics + practice positioning. Deliverable: modern medical device quality and compliance practice.

How this addresses your situation

Specific modules that map to what you said you are dealing with.

Module 1 covers the landscape.

Modules 2 to 4 produce ISO 13485 + FDA QSR alignment, EU MDR/IVDR transition, and AI/SaMD regulatory framework.

Module 5 covers risk management.

Module 6 covers post-market surveillance.

Module 7 covers cybersecurity.

Module 8 covers technical documentation.

Module 9 covers notified-body and FDA engagement.

Module 10 covers engagement economics.

Module 11 covers practice positioning.

Module 12 covers the 10-week build plan.

What you get with this course

The 12-module course delivered as text plus downloadable templates.
Templates and worked examples for ISO 13485 + FDA QSR alignment, EU MDR/IVDR transition framework, AI/SaMD regulatory framework, risk management framework, post-market surveillance framework, cybersecurity overlay, technical documentation framework, notified-body and FDA engagement, engagement economics, practice positioning.
A hand-built implementation playbook generated for your specific client mix.
Three worked examples of modern medical device quality and compliance practices at peer consultants and small device makers.
Scripted talking points for the client Head of Quality and Head of Regulatory Affairs engagement.

What you will have in hand by Day 1, Week 1, Month 1

Day 1: ISO 13485 + FDA QSR alignment scaffold drafted.

Week 4: EU MDR/IVDR transition + AI/SaMD framework designed.

Week 8: Risk + PMS + cybersecurity + technical documentation operational.

Week 10: Modern practice in operation.

Before and after

Before

Your practice handles classic QMS gap analysis and audit-prep work. EU MDR/IVDR transitions consume bandwidth. FDA QSR February 2026 transition lurks. AI/SaMD compliance is reactive. Cybersecurity overlay is patchy. Senior client work goes to peers shipping the modern practice.

After

A modern medical device quality and compliance practice is in operation. ISO 13485 + FDA QSR alignment framework, EU MDR/IVDR transition framework, AI/SaMD regulatory framework, risk management framework, post-market surveillance framework, cybersecurity overlay, technical documentation framework, notified-body and FDA engagement, engagement economics, practice positioning are all designed.

What happens if you do not address this

Quality consultants without the modern practice miss senior client work. FDA QSR transition (effective February 2026) is a forcing event for every US device maker.

Who it is for

For independent medical device quality consultants, principals at boutique med-device compliance practices, senior consultants at mid-tier QA/RA firms, and quality leaders at device manufacturers.

Who this is NOT for. Pure clinical-trial consultants without quality/compliance scope. Consultants at firms with no medical device business. Pure regulatory affairs roles without quality scope.

How it arrives

Text-based course via LMS, plus downloadable templates and worked examples and the hand-built implementation playbook.

Time investment. Roughly 18 hours of reading and 60 to 120 hours of consultant effort across the 10-week build.

Why $199 is the right number

External medical device quality consultants (specialist firms like Emergo, Greenlight Guru consulting, Maetrics, NSF, Oriel Stat A Matrix, Med Device Online consulting) charge $200K-$1M for QMS modernisation programmes. Big4 life-sciences practices charge $300K-$2M for complex transition programmes. $199 buys the focused playbook plus the implementation document for your specific client mix.

FAQ

Will this replace hiring a med-device quality consultant?

Partially. It teaches the modern practice. You may still want specialist input for complex notified-body engagement.

What if my clients are primarily IVD (not medical device)?

Module 3 covers IVDR transition in depth.

Does this cover combination products (drug-device)?

Modules 2 and 9 cover combination-product patterns.

What about FDA 510(k) Predetermined Change Control Plans (PCCP) specifically?

Module 4 covers PCCP in depth.

What is in the implementation playbook for me specifically?

QMS alignment framework tailored to your client mix; EU MDR/IVDR transition framework matched to your specific client devices; a 10-week build plan.

30-day money-back guarantee. If after a week of working through the materials this is not what you needed, reply to the receipt email and a full refund is processed. No questions, no forms.

Within 24 hours your account in the learning environment is provisioned and the tailored implementation playbook is delivered alongside it.