Consulting

We can help with all aspects of safety compliance and be your go to expert for issues that may arise.

We have expertise in the IEC 60601 family of standards and related process standards such as Usability process, IEC 60601-1-6 and IEC 62366, Risk management process, ISO 14971, and Software process, Clause 14 and IEC 62304. We have experience in the following topics.

  • Review process standards needed for IEC 60601 compliance like:
  • Usability process, IEC 60601-1-6 and IEC 62366,
  • Risk management process, ISO 14971, and
  • Software process, Clause 14 and IEC 62304
  • Prepare insulation diagram for product
  • Define Essential Performance

Consulting services include

  • Design reviews
  • Question that came up during an audit
  • On Site safety engineer for a project. Consider us to help with your short term medical device compliance needs