Independent learning for medical-device professionals
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LEARNING

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

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

Safety, performance and evidence

Industrialisation

  • MTL-109Design transfer
  • MTL-110Manufacturing and production
  • MTL-125Supplier and outsourced-process control
  • MTL-126Production-process validation
  • MTL-123Packaging, transport and shelf life
  • MTL-124Sterilisation and microbial control

Release and lifecycle support

  • MTL-111Post-market support
  • MTL-122Labelling and information supplied
  • MTL-127Configuration and change management
Nine 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

  • MTL-209Verification engineers and test laboratories
  • MTL-210Quality teams
  • MTL-211Regulatory teams
  • MTL-212Risk management teams
  • MTL-213Cybersecurity engineers

Industrialisation and product support

  • MTL-215Manufacturing teams
  • MTL-216Supplier management teams
  • MTL-217Service teams
Six role-based topics now available
03

Standards & Guidance

Understand how major standards and regulatory expectations influence development work and objective evidence.

International standards

Regulations

  • MTL-307EU MDR and IVDR General Safety and Performance Requirements
  • MTL-320US FDA Medical-device Regulations — 21 CFR overview

Audit and quality frameworks

  • MTL-321Medical Device Single Audit Program (MDSAP)

FDA guidance

  • MTL-308Cybersecurity in Medical Devices
  • MTL-309Device Software Functions — Premarket Submissions
  • MTL-310Human Factors and Usability Engineering
  • MTL-311Computer Software Assurance for Production and Quality Systems
  • MTL-312Changes to Existing Devices and Software
  • MTL-313Interoperable Medical Devices

EU and MDCG guidance

  • MTL-314MDCG 2019-11 — Software Qualification and Classification
  • MTL-315MDCG 2019-16 — Cybersecurity
  • MTL-316MDCG 2020-1 — Clinical Evaluation of Medical Device Software
  • MTL-317Post-market Surveillance, PMCF and PSUR Guidance

IMDRF guidance

  • MTL-318Software as a Medical Device Principles and Clinical Evaluation
  • MTL-319Principles and Practices for Medical Device Cybersecurity
Four standards topics now available