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.