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Regulatory Affairs For Digital Health & Ai Medical Devices
Published 1/2026
MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz, 2 Ch
Language: English | Duration: 6h 3m | Size: 5.64 GB [/center]
EU MDR, FDA & AI Medical Devices: SaMD compliance, technical file, GSPR, cybersecurity & audit-ready checklists
What you'll learn
Define Digital Health, SaMD and AIaMD-and set intended use and claims that align with regulatory expectations (EU/US)
Decide if your software is a medical device using practical qualification logic for EU MDR/IVDR and US FDA pathways
Classify medical device software under EU MDR/IVDR (including Rule 11 pitfalls) and choose the right conformity route
Build an EU MDR technical file for software: architecture, risk, V&V, clinical evidence, labeling, and traceability
Create a robust GSPR mapping: link every Annex I requirement to evidence without gaps (audit-friendly and reviewer-ready)
Plan clinical and performance evidence for SaMD/AI: validation structure, clinical relevance, and RWE positioning
Apply cybersecurity-by-design: threat modeling, SBOM basics, security testing, vulnerability handling, and documentation
Run a "minimum viable QMS" and regulated software lifecycle: change control, versioning, release management, CAPA
Use final EU/US readiness checklists to prepare for Notified Body audits and FDA pre-submissions/submissions
Requirements
No specific requirements
Description
This course contains the use of artificial intelligenceDigital Health products can scale quickly-but when your solution becomes Software as a Medical Device (SaMD) or includes AI/ML medical device functions, regulatory expectations change dramatically. This course is a practical guide to navigating EU MDR/IVDR and the US FDA approach to software, CDS, and AI, with a strong focus on what teams need to deliver in real life: a clear regulatory strategy, defensible evidence, and documentation that withstands review.You'll learn how to define intended purpose, intended use, and claims-your true regulatory starting point-and how to determine whether your product is a medical device in both the EU and the US. We'll cover how to classify medical device software under EU rules (including common Rule 11 pitfalls) and what it means operationally when a Notified Body is involved.From there, we move into execution: how to build a defensible technical file for medical device software, how to create a GSPR mapping that links every Annex I requirement to concrete evidence, and how to run a regulated software lifecycle with change control, versioning, release management, complaints, CAPA, vigilance, and post-market metrics. You'll also learn cybersecurity-by-design as a patient-safety discipline-threat modeling, security testing expectations, vulnerability handling, and how to document it properly.If you want to position your digital product for smoother audits, faster reviews, and fewer regulatory surprises, this course gives you the frameworks, checklists, and real-world examples to get there.
Who this course is for
Regulatory Affairs and Quality professionals working on Digital Health, SaMD, AI medical devices, and device software
Product managers, clinical leads, and project managers involved in regulatory strategy, evidence planning, and submissions
Software engineers, data scientists, ML teams, and cybersecurity specialists building regulated healthcare software
Founders and startup teams preparing for EU MDR/IVDR, Notified Body reviews, or FDA interactions
Consultants and market access/medical affairs professionals needing a clear regulatory understanding of digital products
Anyone transitioning from "health app" development to regulated medical device software compliance
HomepageScreenshot
Regulatory Affairs For Digital Health & Ai Medical Devices
Published 1/2026
MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz, 2 Ch
Language: English | Duration: 6h 3m | Size: 5.64 GB [/center]
EU MDR, FDA & AI Medical Devices: SaMD compliance, technical file, GSPR, cybersecurity & audit-ready checklists
What you'll learn
Define Digital Health, SaMD and AIaMD-and set intended use and claims that align with regulatory expectations (EU/US)
Decide if your software is a medical device using practical qualification logic for EU MDR/IVDR and US FDA pathways
Classify medical device software under EU MDR/IVDR (including Rule 11 pitfalls) and choose the right conformity route
Build an EU MDR technical file for software: architecture, risk, V&V, clinical evidence, labeling, and traceability
Create a robust GSPR mapping: link every Annex I requirement to evidence without gaps (audit-friendly and reviewer-ready)
Plan clinical and performance evidence for SaMD/AI: validation structure, clinical relevance, and RWE positioning
Apply cybersecurity-by-design: threat modeling, SBOM basics, security testing, vulnerability handling, and documentation
Run a "minimum viable QMS" and regulated software lifecycle: change control, versioning, release management, CAPA
Use final EU/US readiness checklists to prepare for Notified Body audits and FDA pre-submissions/submissions
Requirements
No specific requirements
Description
This course contains the use of artificial intelligenceDigital Health products can scale quickly-but when your solution becomes Software as a Medical Device (SaMD) or includes AI/ML medical device functions, regulatory expectations change dramatically. This course is a practical guide to navigating EU MDR/IVDR and the US FDA approach to software, CDS, and AI, with a strong focus on what teams need to deliver in real life: a clear regulatory strategy, defensible evidence, and documentation that withstands review.You'll learn how to define intended purpose, intended use, and claims-your true regulatory starting point-and how to determine whether your product is a medical device in both the EU and the US. We'll cover how to classify medical device software under EU rules (including common Rule 11 pitfalls) and what it means operationally when a Notified Body is involved.From there, we move into execution: how to build a defensible technical file for medical device software, how to create a GSPR mapping that links every Annex I requirement to concrete evidence, and how to run a regulated software lifecycle with change control, versioning, release management, complaints, CAPA, vigilance, and post-market metrics. You'll also learn cybersecurity-by-design as a patient-safety discipline-threat modeling, security testing expectations, vulnerability handling, and how to document it properly.If you want to position your digital product for smoother audits, faster reviews, and fewer regulatory surprises, this course gives you the frameworks, checklists, and real-world examples to get there.
Who this course is for
Regulatory Affairs and Quality professionals working on Digital Health, SaMD, AI medical devices, and device software
Product managers, clinical leads, and project managers involved in regulatory strategy, evidence planning, and submissions
Software engineers, data scientists, ML teams, and cybersecurity specialists building regulated healthcare software
Founders and startup teams preparing for EU MDR/IVDR, Notified Body reviews, or FDA interactions
Consultants and market access/medical affairs professionals needing a clear regulatory understanding of digital products
Anyone transitioning from "health app" development to regulated medical device software compliance
HomepageScreenshot
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