ABSTRACT
Why? Risk management has become a hot topic as of late with both government Regulatory Authorities (e.g., FDA) and Notified Bodies. With the increasing number of adverse event reports and recalls, it becomes more important than ever to manage and control risks associated with the use of medical devices. Consequently, the earlier in the design and development process that you begin examining device risk, the better for everyone-especially the bottom line. We all know that the earlier you can identify a potential and/ or real problem and fix it, the less costly and certainly less damaging to the company’s reputation. It does absolutely no good to rush a device to market only to have to recall it shortly thereafter.
