According to a McKinsey Business Case for Medical Device Quality, Non-routine quality events—such as major observations, recalls, warning letters, and consent decrees, along with associated warranties and lawsuits—cost the industry between $2.5 billion and $5 billion per year on average (Global). This includes $1.5 billion to $3 billion per year on non-routine costs, plus $1 billion to $2 billion in lost sales of new and existing products…
Quality and safety are the key words in healthcare. A solid Quality Management System and a comprehensive Risk Management can reduce costs and support regulatory compliance.
This session will be open buy Key presentations and followed by discussion:
Presentations: Overview of Quality management Systems for Medical devices Risk Management and the ISO standards 14971