Limited Testing
For clinical trials and other pre-market use, limited testing is a great option. A limited review of the design will be performed in order to create and execute an appropriate test plan to evaluate the applicable clauses within the desired standard(s). Typical outputs of a limited testing project are a Letter Report including a copy of all test data.
Additional evaluation can be added to a limited testing project including, but not limited to the following:
- Insulation diagram preparation
- Labeling & marking review
- IFU (instructions for use) review
- Preliminary critical components review