Electrical energy brings several types of medical devices to life. An active medical device means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy.

Controlled or not by a computerized system, active devices present challenges during design. As an example, it is essential for risk management mitigations to be correctly balanced between software and hardware. The 60601-1 standard is one of the most extensive and comprehensive sources of requirements for designers. The downside is that the probability of a design to not completely fulfill the expectations is statistically high.

In an initial step, Medidee supports the active medical device manufacturers by:

  • Aligning risk management with intended use
  • Identifying the applicable standards and supplying training of development resources
  • Confirming the type of applied parts B, BF, CF
  • Select the applicable clauses of 60601-1
  • Conducting technical assessments and proposing possible hardware and software mitigations

Another area of attention is related to the frequent subcontracting of design activities such as electronics and firmware. The control of such outsourced design activities requires the deployment of proportional controls.

During the testing phase, Medidee supports the company selecting the right test laboratories and even organizing initial cost-effective pre-tests.

Medidee acts as a partner from design to industrialization.

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