The U.S. Food and Drug Administration (FDA) is responsible for regulating the development of and manufacturing processes for medical devices. The FDA also determines the necessary requirements before these medical devices can hit the markets. It’s crucial that FDA design controls are strictly followed in the process of product development.
However, designing a medical device and testing it to prove that it works is not sufficient in the eyes of the FDA to provide a safe product for users. Medical device designers, developers, engineers and manufacturers must be intimately familiar with the FDA’s requirements that ensure a product is safe for use before it reaches the markets.
In this Virtual Boot Camp, Edwin Waldbusser
will guide you on how to comply with the FDA’s requirements for designing and testing a medical device.
- What is design control?
- When does it start?
- Why hazard analysis following ISO14971 is the best risk control method
- Human factors following new FDA guidance and ISO 62366
- Why software validation is more than testing