Complying, as a Hospital, with the FDA’s Recommendation for a Formal Quality Management System

This presentation will include discussion of the medical device service industry and major developments from the past three years as well as an explanation as to why Christiana Care Health System committed to this process. Mike Powers will touch on quality management in an informal state to meet industry standards and risk management as a component of that followed by a description of the certification, the journey to certification and the pitfalls along the way. Wrapping up with a discussion regarding the benefits and drawbacks to the ISO 9001 certification in this industry as an in-house program.

G. Blake Collins, MBA, CBET, CHTM, FABC, Director, Clinical Engineering, and Mike Powers, MBA, CDP, Clinical Engineering Supervisor, Christiana Care Health System

G. Blake Collins, MBA, CBET, CHTM, FABC, Director, Clinical Engineering, and Mike Powers, MBA, CDP, Clinical Engineering Supervisor, Christiana Care Health System