All-in-one Software Solution and Expert Consulting for Medical Device and Drug Combination Product Design Controls, Risk Management, Cybersecurity, and Safety Assurance Cases
GessNet’s mission is to advance medical product safety engineering by providing the industry best practice-based software solutions and expert consulting. It is an extraordinary honor and privilege to have our board members join us on this journey. Together, we will provide our clients with the best-in-class software tools and services.
Mr. Watson is a highly respected regulatory leader in drug device combination products, digital health, human factors, and assurance cases. He has served in executive leadership positions at biotech, pharmaceutical, and digital health companies for the past 10 years.
Prior to his time in industry, Mr. Watson spent nearly 20 years in CDRH at FDA serving as a medical device reviewer, branch chief, and Division Director for a variety of devices, including General Hospital / Drug Delivery Devices. He also serves on industry coalitions, standards organizations, and speaks on topics regarding combination products, human factors, and digital health.
With over 39 years’ experience and devotion, and as a ASQ fellow, Mr. Bills has earned himself as a globally recognized thought leader and subject matter of expert in the field of medical product risk management and quality. He has been a key contributor to the development of international standards such as ISO 14971, ISO TR 24971:2020, and AAMI TIR 105 combination products risk management. He also serves on the US national committee for ISO 13485 and IEC 60601s.
Through consulting, authoring, and training programs at AAMI, PDA, institutions such as University of Southern California, University of Washington, Purdue University, Virginia Tech, Mr. Bills has been sharing his knowledge and wisdom on how to make and maintain safe and effective medical products.