3D/ AM printing can create many types of medical devices from metals, plastics, hydrogels, and even biological materials.New terms, materials usage / application, unique device construction, all raise new metrics and quality concerns.The US FDA recognizes this growing technology and customization, and future possible organ replacement potential as well, and has formed their own Additive Manufacturing of Medical Products (AMMP) area within the FDA, having state of the art manufacturing equipment and research methods to try to get ahead of the curve. They have also published an initial start at industry guidance with a new document.This webinar will consider the FDA’s publishedguidelines / concerns, the technological and regulatory challenges, and methods a company must consider to address and successfully master this new and growing technology.
Additive Manufacturing (AM) or 3D Printing for manufacturing of medical devices is a new and rapidly expanding field, with rapidly expanding regulatory concerns. What is it? What are the US FDA stated concerns? This webinar will focus on the key elements of AM, the concerns, and a recent Dec 2017 guidance document on the subject. Medical device companies have begun adopting additive manufacturing, also known as 3D printing, to create devices that were previously impossible to make, of limited market size, personalized to a specific population or a patient, or some combination.
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years experience in U.S. FDA-regulated industries, 19 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.