October 5, 2020
Part 1 - Steps to simplifying the medical equipment testing process
As you develop new medical equipment, a couple of things can be done to make your testing and certification process easier. Early in the process, you will be outlining a set of requirements that should include the standards that will be applied to your product once developed. With this information, you can review the requirements and ensure they will all get integrated into the equipment. In addition to understanding what can and cannot be done within the construction phase, it will also be critical to the testing and certification process.
Plan for compliance
Since the compliance landscape can be very challenging, setting a path in place early will allow your team to make decisions on design considerations. Additionally, when submitting for evaluation, you can clearly tell the testing agency what needs to be applied to your product. Prepared with this information, you will be able to speed up the time to receive a quote.
You should also start considering the items that will be required for that testing and certification process. The following is a general list of information that will be required for any testing and certification process:
- Intended use of the product
- Multiple units for evaluation and/or additional parts
- All model numbers being submitted with information on model variations.
- Instruction manual
In future newsletters, we will expand on the four items noted above. Additionally, we will discuss the items required for different standards being used for the submission (ex: how these items apply to the EMC standard IEC 60601-1-2 and what additional items need to be submitted).