President and Principal Advisor
Yu Zhao has over twenty years of leadership experience in the medical device industry, including 16 successful years at Medtronic, a world leader in medical technologies, where he held successive leadership roles including that of director and interim vice president for several multi-billion-dollar business units.
Yu founded Bridging Consulting LLC in 2020, gradually expanding his team during the months that followed to include a diverse group of highly accomplished expert consultants worldwide. Since then, he and his team have worked with clients from all around the world whose companies range from four-person AI startups to mid-sized companies to the largest global medical device corporation with over 100,000 employees.
Proven Track Record
Yu has a proven track record of developing world-class regulatory organizations, advocating before the U.S. FDA, China NMPA and other regulatory agencies, formulating innovative regulatory strategies and successfully navigating tricky dynamic global medical device regulatory processes. He and his teams have obtained more than 150 FDA approvals, including PMAs and PMA supplements, IDEs, 510(k)s and De Novos.
Digital health, mobile apps, clinical decision support (CDS) software, SaMD, SiMD, general health and wellness products
Artificial intelligence (AI) and machine learning (ML) devices
Closed loop systems (e.g., artificial pancreas)
Implantable systems (e.g., deep brain stimulation, spinal cord stimulation and implantable infusion pump)
Regulatory strategies and FDA negotiations
Quality management system
Pre- and post-market clinical strategies
Ad/promo, social media compliance
Michael J. Sarrasin
J.D., Principal Advisor
Mike Received his B.A. in biology from Harvard University, in Cambridge, Massachusetts, and his Juris Doctorate, from the Massachusetts School of Law, in Andover, Massachusetts. Most recently, Michael held the position of Senior Director for Regulatory and Clinical Affairs for Tandem Diabetes Care, a San Diego, California company that designs and develops insulin pumps, software and applications for the diabetic marketplace. Under his leadership and guidance, Mike’s group was responsible for numerous groundbreaking FDA approvals, including those for the first ever inter-operative diabetic pump devices (still in use today), including the Alternate Controller Enabled (ACE) insulin pump, the Control-IQ and Basal-IQ algorithms, smart phone-initiated remote bolus devices, and a remote control insulin pump using smart phone technology.
Mike has significant experience in writing, preparing, and executing 510(k), De-Novo, Investigational Device Exemptions, and PMA applications. His background includes expertise in worldwide regulations and their implementation, as well as the management and conduct of various complex clinical studies worldwide. He has a wide range of experience in setting up new company quality systems for implementing quality remediation and system rebuilding. He also has significant experience in dealing with FDA and Notified Body inspections, FDA form 483 inspection reports, warning letters, warning letter remediation, and negotiations with FDA and the Department of Justice.
Mike is experienced in all facets of regulatory, quality, and clinical affairs, having worked for a variety of both large and small companies, including Whalen Biomedical, Kimberly Clark, Lysonix, Tandem Diabetes Care and DAKO Corporation. He began his career with the Millipore Corporation in Bedford, Massachusetts, in the research health group, working on PMA and 510(k) applications for various medical products. Collectively, he has accumulated an impressive total of more than 30 years’ experience.
Gregg W. Van Citters
PhD, Principal Advisor
Gregg has worked in the medical device industry for over 15 years, in diverse areas including clinical research, Lean/Six Sigma process improvement, design for reliability and manufacturability, change management and quality management systems. He was a certified Lean/Six Sigma Black Belt—as well as a quality systems manager—with Medtronic Diabetes for seven years, overseeing quality management system, including design history file and risk management file remediation projects. He oversaw the risk management process for Beckman Coulter and Advanced Bionics, leading design history file and risk management file remediation projects, as well as multiple new product development projects. He consulted for medical device and in vitro diagnostics companies, managing design controls, including design specifications, verification and validation testing and management of safety, cybersecurity and usability risks.
Gregg holds two B.S. degrees—one in mathematics and another in chemistry—from Norwich University, an MS in food and human nutrition from California State Polytechnic University, Pomona, and a PhD in physiology and biophysics from the University of Southern California. Before joining the medical device industry, he worked as a post-doctoral fellow and assistant professor in drug discovery at City of Hope National Medical Center.
Daniel Albahari has more than 17 years of hands-on experience in the medical device and healthcare industry, consulting for local and international companies focused on regulatory and quality issues relating to medical devices and combination products for marketing in Europe, as well as the US and Israel.
Daniel's specialties include medical device and combination product submissions, regulatory affairs strategy, quality assurance, quality systems, risk management, ISO 13485 & FDA audits, EU-MDR CE marking, MDD-MDR transition, clinical evaluation, literature reviews, PMS & PMCF, and quality agreements with economic operators.
Daniel successfully negotiates innovative and cost-effective regulatory solutions with EU notified bodies, competent authorities, and the US FDA. He and his colleagues have obtained dozens of MDD and MDR CE markings for all product classes and numerous FDA 510(k) and Israeli approvals.
Daniel holds a B.Sc. in molecular biology and physiology from the University of Belgrade, an M.Sc. in structural & molecular biochemistry from the Hebrew University of Jerusalem, and a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society.
Combined Years of Experience
Located Across Three Continents
Drawing on a rich font of experience in the medical device industry, our team members are headquartered in Los Angeles, with 15+ BRIDGING CONSULTING LLC expert consultants based across North America, Europe, the Middle East and Asia. On average, each expert consultant has over twenty years’ experience in clinical research, biostatistics, design and development, testing, risk management, regulatory affairs, quality system, compliance and other areas.
LOS ANGELES • Santa Cruz • Boston • San Diego • Riverside