Quality Systems and Product Development

Bryan Wong is a quality assurance and regulatory professional with over 20 years of experience in the regulated medical device industry where he has successfully implemented and improved 21 CFR 820, ISO 13485, and MDD compliant quality management systems for small to medium sized-start ups. He has played a key role in the effective implementation of design controls and risk management in the product development of Class II and III medical devices. Mr. Wong has also contributed to the preparation and submission of technical files and 510(k)s for new products and has successfully navigated multiple regulatory audits. He holds a B.S. in Electrical Engineering and Computer Science from UC Berkeley.
For more information, please contact Bryan at bryan@biomdg.com.