AI & Machine Learning in Medical Devices: Regulatory Compliance & GMLP
FDA, EU MDR and EU AI Act expectations for AI-enabled devices — GMLP, PCCP, validation and post-market monitoring
A professional SkillMed Pro programme on regulating AI and machine learning in medical devices. Across 11 practical modules you learn SaMD basics, the FDA TPLC approach, EU MDR and the EU AI Act, the 10 GMLP principles, data governance and bias, ISO 14971 risk management for AI, IEC 62304 lifecycle, FDA pathways and PCCPs, clinical performance metrics, drift monitoring and audit readiness. Includes 3 knowledge checks, a 25-question exam at 80% and a verifiable certificate.
Standards-based
FDA GMLP & PCCP, EU MDR, EU AI Act, ISO 14971, IEC 62304.
Practical tables
Metrics, pathways and decision flows in every module.
Case studies
AI triage audit, drift investigation and PCCP scenarios.
11 practical modules · 25-question exam · certificate included
- 11 practical modules
- 5 knowledge checks & case studies
- 25-question final exam
- Certificate at 80% pass
Understand → Regulate → Build → Validate → Monitor
Implementation-focused, not theory-heavy — you do the work an AI device regulatory team does.
Understand
SaMD, locked vs adaptive models and AI-specific risks.
Regulate
FDA TPLC, EU MDR, EU AI Act and GMLP principles.
Build
Data governance, bias control, risk and IEC 62304 lifecycle.
Validate
Clinical performance metrics, AUROC and PCCP submissions.
Monitor
Drift monitoring, PMS and audit readiness.
Topics covered
Each module has tables, flowcharts, audit tips and key takeaways.
- SaMD & AI/ML fundamentals
- FDA TPLC & EU MDR Rule 11
- EU AI Act (2024/1689)
- GMLP 10 guiding principles
- Data governance & bias
- ISO 14971 for AI & cybersecurity
- IEC 62304 ML lifecycle
- FDA pathways & PCCP
- EU MDR + AI Act dual conformity
- Sensitivity, specificity & AUROC
- Drift monitoring & PMS
- 10-point audit checklist
What you get
11 practical modules
Tables, flowcharts, audit tips and three investigation case studies.
3 checkpoint quizzes
Test your recall after modules 3, 6, 9, 12 and 15.
25-question exam
Final assessment with a 80% pass mark.
Verifiable certificate
Download instantly on passing, with a unique verification ID.
How enrolment works
Sign in
Use the email address that should receive course access.
Pay securely
Use the Enroll Now button to pay ₹99 through Cashfree.
Access activated
We verify the payment and switch on access for your registered email.
Who this programme is for
Regulatory affairs, QA, SaMD engineers, data scientists, clinical evaluators, auditors and consultants working with AI-enabled medical devices
Curriculum
Full lesson content unlocks once your access is granted.
11 modules · exam · certificate