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
- MTL-114Electrical and electronic designRead topic →
- MTL-115Mechanical design and materialsRead topic →
- MTL-107Software lifecycleRead topic →
- MTL-108Medical-device cybersecurityRead topic →
- MTL-116Usability and human factorsRead topic →
- MTL-121Data, connectivity and interoperabilityRead topic →
- MTL-129Privacy and data protection by designRead topic →
Safety, performance and evidence
- MTL-104Design controls and technical documentationRead topic →
- MTL-105Risk managementRead topic →
- MTL-117Biocompatibility and chemical safetyRead topic →
- MTL-106Verification and validationRead topic →
- MTL-118Electrical safety and electromagnetic compatibilityRead topic →
- MTL-119Reliability, durability and environmental robustnessRead topic →
- MTL-120Clinical and performance evaluationRead topic →
- MTL-128Statistical methods and measurement assuranceRead topic →