Why choose us?
30 years developing and manufacturing complex diagnostic and life science products in both large and small company environments. Experience in both laboratory and POC products allows us to tailor the approach to your needs. Executive-level experience from project planning and management thru manufacturing transfer, launch and operations/service support. We offer affordable, hands-on, executive level experience when you need it most...at the beginning.
Outsourcing Development and Manufacturing?
Know what to outsource, what to keep in-house and how to manage the process and your budget. We have worked with several contract development and manufacturing firms. Each has a unique set of skills. Let us help you select the right partner and put the proper controls in place.
Do Quality Systems make you shudder?
Extensive hands-on experience with designing and implementing lean 21CFR 820 and ISO 13485 compliance quality systems that fit your early stage environment. Our approach synchronizes the implementation of the Quality System elements with the appropriate project phase. Visit our Templates page for some examples