Markets: Medical

We have a wealth of experience in a range of healthcare areas, from early symptom diagnostics to therapeutic solutions for some of the most demanding medical challenges.  Our application experience includes medical devices and instrumentation, pharmaceutical/drug delivery systems, as well as life sciences research.  Our manufacturing software systems provide an industry-leading level of traceability and eDHR documentation.

We understand medical industry regulatory standards. Our Product Development services include stringent quality controls across the Total Product Life Cycle, including requirements definition and development, technical design reviews, design verification, risk management, and analysis. Our proven processes comply with the FDA’s Quality Systems Regulation 21 CFR Part 820, as well as ISO 13485:2016. We create and maintain compliant DHF and DMR packages to support our customer FDA submissions. We also have accreditation in Japan as a Foreign Medical Device manufacturer.

Wherever you are in the product development process, from early concepts or any step along the way, we can design and manufacture the complex technologies required for a wide range of medical products, including imaging, optics, measurement, and analysis of critical healthcare functions.