This webinar will focus on the application of Risk Management throughout the Product Lifecycle.
Some level of risk exists in virtually everything we do. From driving a car, to heating our homes, to ordering a meal in a restaurant, there is some level of risk. We make a decision that the benefits of our actions outweigh the risks associated.
By their very nature and application, there is an element of risk in the use of any Medical Device. Understanding, balancing, and quantifying that risk enables a manufacturer to bring a product to market that provides significant benefit to patients and health care providers, while minimizing the risks associated with the product.
This free 60-minute webinar will focus on the application of Risk Management (Risk Analysis, Risk Evaluation, Risk Control, Overall Residual Risk Evaluation, Production and Post Production Monitoring) as a product moves through the Product Lifecycle (Concept, Development, Launch, Post Market, Obsolescence).
Specifically this webinar will cover:
Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Visit our homepage to learn more.
Mike Baca graduated from the United States Military Academy at West Point in 1976 with a Bachelor of Science degree. He served as an Officer in the Field Artillery Branch of the US Army.
After the military, Mike joined Johnson & Johnson in 1981, working there for 22 years progressing through numerous assignments of increasing responsibility in the Quality and Regulatory disciplines through four operating companies and Johnson & Johnson Corporate as a Quality and Compliance Services Account Director responsible for Corporate oversight of several Medical Device Implant Divisions. In 2003, Mike joined Medtronic, serving as head of Quality in the Neuromodulation and later Cardiac Rhythm Disease Management divisions. He joined Stryker Instruments in May of 2010 as the Global Vice President of the Instruments Division, responsible for Quality Assurance, Regulatory Affairs, and Clinical Sciences. He retired in November 2017. He formed White Rook Consulting LLC in 2019, consulting in his areas of expertise.