Risk is everywhere, and is the primary cause for many types of regulations. This applies to medical products. Regulations ensure medicinal products, medical devices and combination products are safe, effective and usable throughout the product lifecycle. In this talk we will review:

• Risk Management as a framework for identification and control of the critical requirements essential to the safe and effective operation/functioning and use of medical products;
• Combination Products Regulatory Framework; and
• Combination Products Risk Management and Essential Performance Requirements