03 - 04 December, 2019 | Millennium Gloucester Hotel London Kensington, London, United Kingdom
Daniel Porter, Mechanical Engineer at FDA

Daniel Porter

Mechanical Engineer

Check out the incredible speaker line-up to see who will be joining Daniel.

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Conference 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