The New Normal — 3D Printing and Digital Manufacturing - Webinar CD/Transcript

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The New Normal — 3D Printing and Digital Manufacturing: Making Sense of New FDA Guidance and Product Liability

Mark Carlisle Levy — litigator and trial attorney at Eckert Seamons — and Richard Underwood — manager at Exponent — analyzes the implications of the FDA’s May 2016 draft Gguidance for stakeholders in the digital manufacturing industry.

In this session you’ll learn:

  • The FDA’s view of 3D printing
  • The FDA’s view of what needs to be regulated
  • How to submit a device for approval
  • Liability issues digital manufacturers face
  • How to address risk management and product liability issues

Order today and gain an analytical understanding of the current 3D printing draft guidance.

  • Quality Managers
  • Quality Engineers
  • Quality Auditors
  • Regulatory Managers
  • Design & Development Managers
  • Design Engineers
  • Production Managers
  • Production Supervisors
  • Manufacturing engineers
  • Members of your transition team

Meet Your Expert Presenters

Mark Carlisle Levy, Esq., Member, Eckert Seamons
Mark Levy has represented Fortune 500 companies in complex commercial litigation in state and federal forums across the country. He has spent most of his career defending pharmaceutical and medical device companies, defense contractors, transportation companies, and manufacturers of products in heavily-regulated industries in claims made by federal, state, and local law enforcement agencies.

Richard Underwood, PhD, Manager, Exponent
Richard Underwood is a Chartered Engineer and Member of the Institution of Mechanical Engineers. He specializes in the tribology and failure analysis of mechanical systems. Richard is a Visiting Research Professor at the Implant Retrieval Centre at Department of Biomedical Engineering and Health Systems at Drexel University, where his research interests include the tribological performance of orthopedic devices. Prior to joining Exponent, Richard graduated with 1st Class Honours from the Mechanical Engineering Department at Imperial College London, where he also studied for his Ph.D. in mechanical engineering tribology.