Subject of Speech

The Lifecycle of Medical Device and Control and Each Phase

The speech will cover

1. Required control at each phase of lifecycle from the view of FDA and EU
2. What constitutes a medical device
3. Lifecycle of a Medical Device
4. New Regulations and Standards to be aware of

Kevin Shao, founder of Sino-American Stephanos Medical Device Solutions, LLC,  has around 30 years of industry experience both in the US and China. His experiences cover from Medical Device, Aero Space, Electronics and Metal Working.

Kevin’s experiences and knowledge in both Quality System Management and Lean Six Sigma make him a very strong resource in the highly regulated, data driven environments

Kevin has been working with both the Global Medical Device leaders such as Medtronic, CareFusion and medical devices companies in China. This provides him a broad understanding of the operations and quality practices of both sides and help him to make the best decisions that fit the culture and requirements from either side.

Kevin has helped multiple companies in US and China to set up and improve their quality systems to meet the requirements of FDA QMR.

Kevin has provided consulting services to multi-billion revenue medical devices companies as well as small startups in both US and China. His consulting work includes dual diligence and integration of multinational acquisition, quality system development, FDA audits, and operational strategies.

Registration
Free online registration is required no later than one day before the event and is limit to the first 70 registrants.

Map


Contact
SABPA OC/LA <sabpa.ocla@gmail.com>