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.

01

Core Medical Device Topics

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

  • MTL-101Medical-device development lifecycleRead topic →
  • MTL-102Intended purpose, users and use environments
  • MTL-103User needs and design inputs
  • MTL-104Design controls and technical documentation
  • MTL-105Risk management
  • MTL-106Verification and validation
  • MTL-107Software lifecycle and cybersecurity
  • MTL-108Manufacturing, transfer and post-market support
Core learning now available
02

Learning by Role

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

Four role-based topics now available
03

Standards & Guidance

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

  • MTL-301ISO 13485 and design controlsRead topic →
  • MTL-302ISO 14971 risk management
  • MTL-303IEC 62304 software lifecycle
  • MTL-304IEC 60601 electrical safety and EMC
  • MTL-305IEC 62366-1 usability engineering
  • MTL-306ISO 11608 needle-based injection systems
  • MTL-307EU MDR and IVDR General Safety and Performance Requirements
  • MTL-308Medical-device cybersecurity guidance
First standards topic now available