We are your one-stop source for medical device testing and validation — for products, materials and packaging. Our expert engineers and technicians provide reliable, quality-assured testing services and documentation throughout every step of the critically important testing and validation process.
A leader and innovator in medical device testing, we offer solutions to medical device development engineers, QA and regulatory affairs professionals to ensure your devices meet all regulatory agency requirements and the highest industry standards.
Medical device manufacturers are required to obtain 510(K) approval on each medical device package. We perform a variety of testing services to ensure compliance with the integrity of the device.
Drug Delivery Device Testing
We have a dedicated unit focused on providing support and testing for compliance with ISO 11608. Our experts perform standard and customized functional, mechanical, force, dimensional/metrology and dose delivery/accuracy testing for drug delivery devices. Testing can be designed to support all life cycle phases of your combination products from early concept and preclinical testing through final product qualification and management of ongoing commercial program support. The laboratory includes on-site preconditioning necessary for testing according to ISO 11608 – Needle-Based Injection Systems for Medical Use.
Contact our analytical testing team by clicking below