Preliminary Evaluation

Want your design or documentation reviewed to identify important considerations and potential compliance issues early on in the design process? Having a Preliminary Evaluation conducted before design freeze is a good way to accomplish this. A Preliminary Evaluation consists of a 1 day deep-dive with a MECA engineer to review the construction of your device and any documentation that is currently available.

  • These evaluations typically occur in-person and can be at your facility or MECA’s.
  • Preliminary Evaluations often include the following activities:
    • Review intended use, accessories, interconnections, and classifications
    • Review and determine applicable standards and project scope (IEC 60601-1, -1-2, -1-6, etc.)
    • Perform a construction evaluation, per requirements in the standard(s)
    • Generate or review/modify an Electrical Insulation diagram
    • Define Essential Performance and associated verification methods, as applicable
    • Review Critical Components for requirements
    • Create applicable test list
    • Review user manual and markings requirements
    • Provide risk management, software, and usability guidance documents
  • The output of this is an email summary of the topics/outcomes covered. A Letter Report can be provided for an additional cost.
  • Preliminary Testing Services are quoted separately from Preliminary Evaluations or Compliance Services.
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