ABOUT US
ABOUT US
Specializing in early stage medical devices, our expert team guides start-up companies through all stages of the product development process. From concept to design to manufacturing.
STEVE ZIEMBA
STEVE ZIEMBA
Steve has More than 30 years of experience in development and management of FDA/ISO-compliant quality systems, regulatory filings and clinical study programs (protocols/ICDs and data analysis systems) for Class I, II and III medical devices in US, EU, Canada, Japan, China, Australia, South Africa, Korea, Brazil and Mexico. He has worked with early stage and multinational ophthalmic, dental, orthopedic, general surgery and cardiovascular device companies. Steve has authored more than 10 original PMAs, numerous PMA supplements, IDEs, 510(k), Q-subs, and Technical Dossiers leading to FDA approvals and CE Marks with several Notified Bodies and other OUS approval agencies.
Steve’s expertise also includes FDA QSR and ISO13485-2016 and MDSAP compliance, 14971-2019 risk assessment/mitigation, protocol/statistical development for initial product design and scale-up validations, HE75 Human Factors studies, Meddev-compliant CERs, PMS/PMCF studies and MDR 2017/745 gap analyses. He has authored/co-authored more than 18 peer-reviewed papers and holds a M.Sc. in Systems Management from the University of Southern California.