Software as a Medical Device (SaMD): Regulatory, Lifecycle & Audit Readiness
Classify, build, validate and maintain medical software under IMDRF, EU MDR, FDA and CDSCO — IEC 62304, ISO 14971, IEC 62366-1 and cybersecurity
A professional SkillMed Pro programme on Software as a Medical Device. Across 10 practical modules you learn SaMD vs SiMD, global classification (IMDRF, EU MDR Rule 11, FDA, CDSCO), IEC 62304 lifecycle, software risk management, usability engineering, cybersecurity and data protection, clinical evaluation, Agile/DevOps in a regulated QMS, post-market change control and audit readiness. Includes 3 knowledge checks, a 25-question exam at 80% and an instant verifiable certificate.
Standards-based
IMDRF, EU MDR, FDA, CDSCO, IEC 62304, ISO 14971, IEC 62366-1.
Practical tables
Classification, pathways and decision flows in every module.
Case studies
ECG app classification, patch release and audit scenarios.
10 practical modules · 25-question exam · instant certificate
- 10 practical modules
- 5 knowledge checks & case studies
- 25-question final exam
- Certificate at 80% pass
Classify → Build → Secure → Validate → Maintain
Implementation-focused, not theory-heavy — you do the work a SaMD regulatory team does.
Classify
SaMD vs SiMD, IMDRF categories, Rule 11, FDA and CDSCO.
Build
IEC 62304 lifecycle, SOUP, Agile and DevOps controls.
Secure
ISO 14971 software risk, usability and cybersecurity.
Validate
Clinical evaluation, verification and technical documentation.
Maintain
PMS, change control, patching and audit readiness.
Topics covered
Each module has tables, flowcharts, audit tips and key takeaways.
- SaMD vs SiMD fundamentals
- IMDRF risk categories
- EU MDR Rule 11 & MDCG 2019-11
- FDA 510(k), De Novo & CDS
- CDSCO software classification
- IEC 62304 safety classes
- ISO 14971 software risk
- IEC 62366-1 usability
- Cybersecurity & SBOM
- Clinical evaluation (IMDRF N41)
- Agile, DevOps & cloud QMS
- 12-point audit checklist
What you get
10 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, software engineers, health-tech founders, clinical evaluators and auditors working with medical software
Curriculum
Full lesson content unlocks once your access is granted.
10 modules · exam · certificate