Why Perform Mechanical Testing

Mechanical testing is a necessary step of any product development cycle for a device requiring regulatory marketing approval.

The results from mechanical testing provide the measure of safety and efficacy needed for the submission, either for a 510K device comparison or to show that the device will not cause harm during clinical trials. Mechanical testing can follow a customer provided protocol, an internationally recognized ASTM or ISO test standard, or a co-developed custom protocol. The goal of any mechanical testing should be to answer specific questions about the strength and performance of the device being evaluated. Correctly identifying the questions and therefore the methodology to answer the questions is as imperative as the testing itself. Thorough planning, including timelines, testing goals, protocol development, costs (including specimen manufacturing), and acceptance criteria will help to ensure that any mechanical testing battery executed will be successful.

Overview

ETC is here to simplify your testing needs. Fill out our easy-to-use estimating form and we'll get back to you within 48 hours.

4628 Northpark Drive
Colorado Springs, CO 80918

Phone: 719.264.9937
Fax: 719.264.1926
info@empiricaltesting.com