03 - 04 December, 2019 | Millennium Gloucester Hotel London Kensington, London, United Kingdom
Daniel Porter
Mechanical Engineer
FDA
Check out the incredible speaker line-up to see who will be joining Daniel.
Download The Latest AgendaConference Day 2
Wednesday, December 4th, 2019
2:20 PM An Example of Using the Additive Manufacturing Guidance from the U.S. Food and Drug Administration
- Review the U.S. FDA 2017 Guidance Document “Technical Considerations for Additive Manufactured Medical Devices” which is intended to help medical device stakeholders with AM aspects of their pre-market submissions
- Convey how a sponsor could use the U.S. FDA 2017 AM Guidance Document for a hypothetical 510(k) pre-market submission using a fictitious patient matched bone plate system
- Discuss considerations such as design, software workflow, material control, post-processing, and final testing
- Focus primarily on the AM aspect of a fictitious 510(k) premarket submission