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Webinar Series

Understanding Qualification and Certification for AM, with a Focus on Medical

September 09, 2022

Friday, September 09, 2022 10:00 AM
— Friday, September 09, 2022 11:00 AM

About the Webinar

The qualification requirements to be applied for medical devices manufactured through additive manufacturing technologies needs additional considerations compared to conventional manufacturing.  This webinar will introduce the steps necessary to qualify an Additive Manufacturing process to produce medical devices and the certification requirements necessary to ensure compliance.

Registration Fee: $49.00 USD

Learning Objectives

After completing this webinar, the attendees will have developed an understanding of:

  • The steps necessary to qualify a manufacturing process for Medical Devices
  • When to Verify or Validate the outputs of a manufacturing process
  • Special considerations specific to AM in medical device production
  • Ongoing verification requirements for production of medical devices

Who Should Attend

Manufacturing Engineers, Research Engineers, AM Process Engineers, Medical Device Manufacturers

Instructor

Ryan Kircher has over 16 years of experience in additive manufacturing of medical devices and other metal AM components. He launched one of the 1st implantable AM medical device manufacturing facilities in the US in 2006. Since helping medical device manufacturers gain FDA 510K clearance of implantable devices in 2009, Ryan has been involved in the development of numerous cleared AM medical devices (Hip, Extremity, Knee, Spine, PMI, CMF, Guiding). Ryan is a Senior Additive Manufacturing Engineer for rms Company, based in Coon Rapids, MN.

AM CoE by the Numbers

With decades of experience in additive manufacturing, our team of experts is integral to our work. With team members located throughout the Americas, Europe, and Asia, the AM CoE is able to provide agile support for global initiatives.

BY THE NUMBERS

combined in-kind, government agency, and ASTM investment
$10M+
projects initiated that will address AM standardization gaps
30+

How can I participate?

  • Support through Research and Development

    Through the AM CoE, research priorities are identified by the top minds in the field and are matched from the start to the standards that need to be generated to ensure the resulting AM technology’s success.

  • Consortium for Materials Data and Standardization

    Consortia for Materials Data & Standardization (CMDS) enables companies of all sizes from across the entire additive manufacturing ecosystem to collaborate on standardizing the best practices for materials data generation.

  • Explore On-Demand Webinars

    The webinar series provides guidance sessions on multiple and diverse topics in AM Design, Fabrication, Post-processing, Mechanical testing, Non-destructive evaluation, Applications, and Qualification and Certification.

  • Education & Workforce Development

    Comprehensive program that educates and trains the additive manufacturing workforce at all levels, while continually incorporating new advances to respond to industry needs and leverage standardization, certification, and AM CoE partner expertise.