The testing and validation process for FDA Class I, II, and III medical devices is a time-consuming and difficult task for many companies. Lack of specialized equipment, access to medical simulation technology and proper documentation practices slow the progress toward conformance demonstrations and getting product launched to meet market demands. There are also times when a product already in the marketplace needs additional testing, validation services and documentation to stay compliant with the ever-changing regulatory climate.
The CAMLS Innovation Center is uniquely equipped to provide nimble, cost-effective testing and validation services including the following:
Sterilization & Packaging Validations
“Timelines in our industry are critical. CAMLS makes available equipment and services that permit new products to be tested and modified within days or weeks rather than months. It allows our small firm to compete successfully by permitting us access to resources normally only available in larger firms.”
Geary Havran, President and Chairman of the Board
NDH Medical Inc.