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We offer IEC 60601-1 Medical Devices Constructional Safety Training, this including:

  • 01

    Basic Safety and Essential performance aspect

  • 02

    Markings and documentation requirements

  • 03

    Electrical safety

  • 04

    Insulation diagrams – creepages & clearances and Means of Protection

  • 05

    Critical Components

  • 06

    Mechanical Construction of Medical Electrical Equipment

This training can be customised to meet your needs in terms of content and is delivered online or face-to-face at your facilities. Customised training can be useful to allow for concentrating on specific aspects of the standard or the training to be built on certain types and construction of Medical Devices.

Usability engineering training to IEC 60601-1-6 & 62366 and Medical Software training to IEC 62304 are offered on request and can be part of the consultancy service.

  • 07

    Temperature Requirements

  • 08

    Single Fault Conditions Aspect

  • 09

    Radiation hazards

  • 10

    Power supply and batteries

  • 11

    Medical Electrical System (clause 16)

  • 12

    Risk Management including ISO 14971 Requirements