Medical Devices

With backgrounds in biochemistry, biomedical engineering, and software development, we have been key in the development of a wide range of novel instrumentation for general chemistry, immunoassays, and molecular and companion diagnostics. We have multiple patents to our credit.

We have also been responsible for the development of novel assays. This work has been instrumental in saving lives and improving health for millions.

In addition to new product, we have extensive experience with process development including manufacturing, support, and verification & validation.

Experience includes Quality and Regulatory Compliance, with experience from NDA to 510(k), including:

• CDRH

• CBER

• 21 CFR (part 11 and section 820)

• ISO 13485

• IDE’s