Independent learning for medical-device professionals
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Independent learning for medical-device professionals
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LEARNING

Choose where you want to begin.

Browse the library from the perspective that best matches your question. Each topic has a permanent MedTechLearning identifier.

MTL-001 · START HERE

Developing a medical device

Intended purpose → Requirements → Risk → Development → Verification → Release → Maintenance

Seven linked stages, a short exercise at each step, and a standalone syringe infusion pump example covering mechanics, electronics and embedded software.

MTL-001 — Begin the learning journey →
01

Core Medical Device Topics

Build a practical understanding of the activities that connect a medical-device idea to a controlled, supported product.

Lifecycle foundations

Product definition and systems

Design disciplines

Software, data and digital health

Safety, performance and evidence

Industrialisation

Release and lifecycle support

Thirty-five core topics now available
02

Learning by Role

Explore the responsibilities, interfaces, decisions and evidence expected from different functions.

Business and organisational leadership

Product and project leadership

Engineering and architecture

Verification, quality and regulatory assurance

Industrialisation and product support

Specialist engineering and evidence

Software, data and lifecycle assurance

Twenty-eight role-based topics now available
03

Regulations, Standards & Guidance

Understand the regulatory framework first, then see how standards and authoritative guidance support compliant development and objective evidence.

Regulations

Using standards for regulatory compliance

International standards

Audit and quality frameworks

FDA guidance

EU and MDCG guidance

IMDRF guidance

Twenty-nine regulations, standards, audit and guidance topics now available
04
APPLIED PRACTICE, FURTHER LEARNING & AI

Apply the learning and keep exploring.

Follow representative products across the development lifecycle and extend your knowledge through carefully selected external resources, professional perspectives and dedicated AI learning.

MTL-4xx

Worked Product Examples & Case Studies

Representative products followed across the complete development lifecycle, showing how specialist work becomes one coherent evidence set.

MTL-401Connected injection deviceExplore →MTL-402IVD analyserExplore →MTL-403Medical-device mobile app and cloud serviceExplore →MTL-404Standalone software as a medical deviceExplore →MTL-405Medical electrical equipmentExplore →MTL-406Sterile single-use medical deviceExplore →MTL-407Combination productExplore →MTL-408Medical AI — from claim to controlled useExplore →
Eight worked examples available
MTL-5xx

AI and Medical Devices

Follow the AI lifecycle from foundations and data through safety, evidence, controlled changes and continuing performance.

MTL-501AI and machine-learning foundations for medical devicesExplore →MTL-502Data governance for medical AIExplore →MTL-503Bias, fairness and representativeness in medical AIExplore →MTL-504AI risk management and human oversightExplore →MTL-505Verification, validation and clinical evidence for medical AIExplore →MTL-506Predetermined change control plans for medical AIExplore →MTL-507Post-market monitoring, drift and model performanceExplore →MTL-508Generative AI and large language models in MedTechExplore →MTL-509AI security, robustness and adversarial resilienceExplore →

Apply this learning with MTL-408 — Medical AI case study. Explore MTL-602 — Applications of AI in Medical Devices and MTL-603 — AI in development and quality management.

Nine AI modules available