The Product electronics and enclosure design were completed and prototype hardware available before we joined the team. Our tasks were to design the Product shipping container and then subject un-packaged and packaged products to a suite of physical environments to verify the product’s suitability for use.

Working with the Client’s staff members, we prepared environmental test protocols for both un-packaged and packaged product based on Product Safety and IEC environmental requirements.

The IEC has provided a suite of Environmental Test Specifications for a wide range of classifications of equipment and environments. We worked with client personnel to select the optimum set of tests and conditions for this particular product, un-packaged and packaged.

We designer and supervised the construction of a test fixture to support the Product during un-packaged shock and vibration testing as the "system under test" had no "means of attachment" for such testing.

We first subjected samples of un-packaged product to the suite of environmental tests chosen for the un-packaged product, using the test fixture when required. Problems were noted and records kept for review.

We then subjected the packaged samples to the suite of environment tests chosen for the packaged product. Problems were noted and records kept for review.

We provided Failure Analysis and Corrective Action assistance when problems were encountered during the testing and assisted with re-testing as required.

We provided Final Reports suitable for FDA Submission upon completion of the Project.