Cooperative Quality Solutions was founded with the goal of helping clients achieve integrated medical device compliance that helps their business succeed.

Jenn Zuba

Founder and Consultant

 

Jenn earned her BS and MS degrees in Biomedical Engineering from Rensselaer Polytechnic Institute.  After school, she worked in new product development where she designed contact lenses and orthopaedic fracture implants and instruments, receiving multiple patents for medical device design. 

Early in her career, Jenn found a passion for developing and improving quality system processes and tools to improve efficiency.  From there, she developed an in-depth knowledge of the regulations and standards governing compliance. Jenn founded Cooperative Quality Solutions to marry her skill set of creating and maintaining quality system processes that are not only compliant, but also help facilitate product development.

Jenn is a member of the Regulatory Affairs Professional Society (RAPS) and the AAMI working groups responsible for writing the EN 62366, HE 75, and ISO 14971 standards. She regularly presents at industry conferences.