Worldwide FDA Experts

  • Regulatory Consulting

    Quality, Compliance and Submissions

  • Registration & Listing

    Medical Devices & OTC Drugs

  • Call 619-517-0673

    For Immediate Assistance
By - Glen Feye

3D Printing Medical Device Manufacturing= Additive Manufacturing

Does your firm use 3D printing and UV Curing systems to manufacture medical devices..then you must validate these systems based on the new implemented Final FDA Guidance Document-“Technical Considerations for Additive Manufactured Medical Devices.” On December 5, 2017,  FDA issued the final version of the guidance, “Technical Considerations for Additive Manufactured Medical Devices.”  Additive manufacturing (AM), the broad category of

Continue reading “3D Printing Medical Device Manufacturing= Additive Manufacturing”