Medical Device Courses

IEC 60601-1 (1 day)

  • Risk Management & relation to ISO 14971
  • Device classification
  • Identification, marking and documents
  • 60601-1 relation to collateral & particular standards
  • Protection against ELECTRICAL HAZARDS
  • Protection against MECHANICAL HAZARDS
  • Protection against other types of HAZARD
  • Programmable electrical medical systems (PEMS) and the relation to functional safety, IEC 62304 and cybersecurity
  • ME SYSTEMS considerations
  • Electromagnetic compatibility (EMC)

 

IEC 62304 (1 day)

  • Risk management
  • Overview of the V Model according to IEC 62304
  • Requirements management
  • Software development plan
  • Software architectural design
  • Software unit design
  • Software integration and verification
  • System integration – relationship to IEC 60601
  • Configuration management
  • Problem resolution
  • Software maintenance
  • Cybersecurity
  • IEC 82304

 

ISO 14971 (half day)

  • ISO 14971 overview
  • Risk management planning
  • The risk management file and responsibilities
  • Interdependencies
  • Risk assessing hazards and intended safety
  • Risk analysis techniques (FMEA, FMECA and FTA)
  • Risk control techniques
  • Risk benefit analysis
  • Post market activities

 

IEC 62366-1 (half day)

  • Overview of the usability processes
  • Risk management relating to usability
  • Planning & inputs (including FDA guidance)
  • Selection of user groups
  • Usability process (hazard-related use scenarios, risk control, formative and summative analysis)
  • Requirements of the User Interface and other specifications
  • User Interface of unknown provenance
  • Risk benefit analysis
  • Post-production activities

 

We offer a variety of additional courses including the Medical Device Regulation and ISO 13485. We also tailor courses to meet your organisation’s individual needs.  Please contact us to discuss any training course requirements you may have.