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Free On-Demand Webinar

The Power of 3D-Printed Medical Devices: Proven Regulatory Strategies & Quality Recommendations to Use for Additive Manufacturing

Watch the webinar


While additive manufacturing (a.k.a. 3D printing) is a forty-year-old process, many medical device firms struggle with determining whether or not it’s appropriate for them to use in making products, validating workflows, and executing compliance strategies.

Register for this free, in-depth webinar to learn from top experts in this field, Sam Murray and Gaurav Manchanda of Formlabs, as they discuss the various 3D printing technologies and how best-in-class medical device companies are utilizing them today, while also providing insights into the key considerations that should be evaluated when validating the workflow. 

Participants will be given actionable recommendations and the guidance to implement a successful quality management system that encompasses the nuances of the computer-aided design and manufacturing (CAD/CAM) process while also meeting all regulatory requirements necessary to successfully commercialize end-use 3D-printed medical devices.

 

Specifically this webinar will Provide:

  • An evaluation of various manufacturing methods and 3D printing technologies
  • Considerations for QA/RA requirements and constraints, including ISO 13485, ISO 10993-1, 21 CFR 820, and EU MDR
  • Recommendations for QMS, design verification and validation, and process validation (IQ/OQ/PQ) while utilizing additive manufacturing for patient-specific or mass-market devices
  • Regulatory considerations for commercialization of 3D printed medical devices in Europe and the United States
  • Case studies to illustrate how 3D printing is used by medical device firms including R&D, manufacturing aids, premarket submissions, and final-use parts

Who should attend?

  • Medical Device Executives
  • R&D Engineers and Management
  • QA/RA Professionals and Management
  • Product Managers, Process Engineers, and Operations Managers
  • Med Device Development Professionals in North America and Europe

Presenter

Sam-Murray

Sam Murray
Director of Regulatory Affairs and Quality Assurance
Formlabs 

Gaurav-Manchanda

Gaurav Manchanda
Director of Medical Market Development
Formlabs

Moderator

 Etienne-Nichols-round

Etienne Nichols
Medical Device Guru
Greenlight Guru

     

 
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About greenlight guru

Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient.

Visit our homepage to learn more.

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ABOUT Formlabs

Formlabs is expanding access to digital fabrication so that anyone can make anything. It has become the all-time best-selling 3D printer for professionals within ten years, with over 80,000 SLA and SLS machines sold, hundreds of thousands of surgeries supported, and over 70 million end-use medical supplies printed by customers in the last 18 months alone. By combining clinically validated 3D printing technology, in-house QA/RA services, and accessible pricing and user-friendliness, the company enables healthcare professionals and medical device engineers to enhance surgery, radiology, orthotics and prosthetics, device development, and device manufacturing. Formlabs has FDA-registered, ISO 13485-certified manufacturing facilities that it uses to produce a range of biocompatible, sterilizable materials. Its solutions have been used in hundreds of clinical publications and are trusted by the world’s leading health systems and medical device manufacturers.

Visit their website to learn more.

 

 

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