April 23-26, 2018 | Fort Worth Convention Center | Fort Worth, TX | Exhibits April 24-26

Regulatory & Quality System Considerations for 3D Printed Medical Devices

Medical Manufacturing Innovations (MMI) Program Workshops

May 8, 2017 8:00 am - 1:00 pm

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WORKSHOP LEADER: Janelle Schrot, Materialise

INSTRUCTORS: Matthew DiPrima, Food & Drug Administration; Kim Torluemke, 3D Systems, Jenny Jones, Materialise; Beatrice Ogembo, American Preclinical Services; Gilbert Cortes, Johnson & Johnson

As the number of medical devices manufactured using additive manufacturing/3D printing technologies continues to increase, manufacturers struggle with the quality, validation, and filing processes to have each device cleared for use. This workshop brings together technology and process experts to walk participants through the considerations at every step as it applied to 3D printed devices. Discussion will include device classes, verification, validation, testing, PMA, IQ, OQ, PQ and more.

Learning objectives:

  • Gain insight into FDA’s view of 3D printing as applied to medical devices
  • Obtain an overview of the types of 3D printed medical devices that have been cleared
  • Understand how quality, controls, validation and verification can be accomplished with 3D printing
  • Learn the latest available information on regulatory clearance processes specific to 3D printing

 

Workshop Agenda

 

8:00 am – 8:15 am

Introduction / Background

Janelle Schrot, Materialise

  • Broad landscape of devices overview
  • History of 3d printed medical devices cleared by the FDA

 

8:15 am – 8:45 am

FDA’s Perspective on 3D Printing for Medical Devices

Matthew DiPrima, US Food and Drug Administration

  • Information / overview on guidance document

 

8:45 am – 9:15 am

V&V Unique to 3D Printed Medical Devices

Gilbert Cortes, Johnson & Johnson

  • Design Verification on medical devices
  • Cleaning and sterilization of medical devices
  • Packaging validation on medical devices

 

9:15 am – 9:30 am

Break

 

9:30 am – 10:20 am

Quality System, Design Control, Validation and Verification

Kim Torluemke, 3D Systems

  • Quality System
    • Additive Manufacturing and the need for a quality system
    • 21 CFR 820.5
    • ISO 13485 and how it relates
  • Design Control
    • Often overlooked, but imperative, design control and how it applies to AM devices
  • 21 CFR 820.3
  • General Verification and Validation Plan
    • Design verification
    • Design Validation
    • Software Validation

 

10:20 am – 10:50 am

Process Validation

Jenny Jones, Materialise

  • Installation Qualification
    • Documented testing and verification
    • Installation per manufacturers specifications; different manufacturers HVAC, power, safety requirements, EOS, 3D Systems, ARCAM, Stratasys, etc.
  • Operational Qualification
    • Test operational limits of process; again walking through a couple of hypothetical work flows of manufacturing and post processing equipment.
  • Performance Qualification
    • Test “normal” operations of process; repeat same work flows or utilize different manufacturing workflows to explain.

 

10:50 am – 11:20 am

FDA clearance process

Beatrice Ogembo,  APS (American Preclinical Services)

  • Information needed
  • How process typically works
  • Brief Mention of OUS regulatory processes highlighting the similarities to FDA
  • Understanding difference & dissimilarities in and outside US

 

11:20 am – 11:45 am

Box lunch

 

11:45 am –12:45 pm

Round Table Discussions

 

12:45 pm – 1 pm

Wrap-Up & Questions/Answers

Janelle Schrot, Materialise

 

Speaker Bios

Gilbert A. Cortes CQE, CQA, MBB

Quality Engineering Director
Johnson & Johnson

Gilbert A. Cortes is a Quality Engineering Director with Johnson & Johnson