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

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