3D Printing for Medical Products: FDA's Current Views and Future Projections

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 minutes
Product Description

Understand FDA’s Current View, Technical Challenges and Assessments while Designing, Developing and Manufacturing 3D Printed Medical Products

 This conference by expert speaker Dr. David Lim is intended to discuss technical considerations while designing, developing and manufacturing 3D printed medical products. In particular, it is intended to present FDA’s current views and perspectives on technical challenges, considerations and assessments relevant and applicable for 3D medical products (e.g., medical devices). 

The presentation will provide great opportunities for you to become aware of and get familiar with FDA’s perspectives on 3D printing. It will discuss what should firms consider and address to expedite FDA’s process of evaluating 3D products in regulatory submissions.

Session Highlights:

  • Applicable Laws and Regulations
  • Definitions
  • FDA Software Documentation and Guidance
  • FDA Perspectives on Printing and Post-Printing
  • FDA Approaches for Printer Control Software
  • Medical Products 3D Printing Technology
  • Medical Products 3D Printing: Pros and Cons
  • Performance Testing Requirements For 3D Printing Technologies
  • Good Manufacturing Practice (GMP) Considerations For 3D Printing
  • Recent Discussion and Trends for 3D Printed Products
  • Examples Of 3D Printed Medical Devices
  • Dos and Don’ts/ Recommendations and suggestions by the speaker

Who Should Attend

  • Healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.
  • Compliance Officers
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • Laboratory Personnel
  • R&D Professionals
  • Consultants
  • Contractors/Subcontractors
  • Other professionals interested in this topic

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
More Events By The Speaker

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