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 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, personalized to the patient, or both.
3D 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 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 with 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.
Areas Covered in the Session :
What is Additive Manufacturing / 3D Printing
The Design-to-Device Process
Methodologies and Materials; Recycling
Printing Characteristics and Parameters
Unique Device Build Characteristics
Standard vs. Patient-Matched Devices
Unique Software Considerations
Physical and Mechanical Assessment of the Finished Device
Acceptance Activities; Test Coupons
Validation / Revalidation
Submission Requirements
Who Should Attend:
Research and Development Departments
Quality Departments
Regulatory Affairs Departments
Manufacturing Departments
Production Departments
Engineering Departments
Operations Departments
Purchasing Departments
Medical products consultants (primarily devices)