The Future of Quality
The hottest topic in the medical device world right now is 3-D printed devices. The world of 3-D printing within healthcare has grown exponentially within the last few years and is expected to be a $22 billion industry by 2022. The FDA has realized this and released a stimulating guidance that serves as a way for the agency to share initial thoughts on this emerging technology and considered to be of public health importance. The FDA guidance was released in December 2017 and is very in-depth and specific on what the FDA is exactly looking for in a pre-market submission. Important information includes benefits and downfalls of 3-D printed medical devices, the types of 3-D printing technologies and printing materials currently being used, and what exactly the FDA is looking for in a pre-market submission. This session will give an in-depth look at current devices on the market that have been FDA cleared, and the performance, mechanical, and dimensional testing required to get your device on the market. Additional information covered includes cleaning and sterilization, biocompatibility testing, and labeling.