8 research outputs found

    Regulatory Considerations in the Design and Manufacturing of Implantable 3D‐Printed Medical Devices

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    Three‐dimensional (3D) printing, or additive manufacturing, technology has rapidly penetrated the medical device industry over the past several years, and innovative groups have harnessed it to create devices with unique composition, structure, and customizability. These distinctive capabilities afforded by 3D printing have introduced new regulatory challenges. The customizability of 3D‐printed devices introduces new complexities when drafting a design control model for FDA consideration of market approval. The customizability and unique build processes of 3D‐printed medical devices pose unique challenges in meeting regulatory standards related to the manufacturing quality assurance. Consistent material powder properties and optimal printing parameters such as build orientation and laser power must be addressed and communicated to the FDA to ensure a quality build. Postprinting considerations unique to 3D‐printed devices, such as cleaning, finishing and sterilization are also discussed. In this manuscript we illustrate how such regulatory hurdles can be navigated by discussing our experience with our group's 3D‐printed bioresorbable implantable device.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/115990/1/cts12315.pd

    The Ursinus Weekly, October 2, 1975

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    Meetings on Perkiomen Valley growth • In memoriam • Gene Shue presents: Year of the Sixers • City planner speaks • Ursinus College appoints Assoc. Prof. of Education • Kane earns Doctorate • Editorial: A different year? • Is there more to life? • New dorms renovated • Saturday Lunch • Forum series opens: Nina Deutsch • Musical notes • Chris Hillman rated • New events at Walnut • Nancy Drew revisited • Alumnus is named to Library post • British history specialist joins Ursinus faculty • Instructor returns to Ursinus • Pa. Dutch Program is success • Instructor appointed to Biology Dept. • Lindback Award presented • Soccer season opens • Ursinus allies with area • Balloons! • Ursinus named a \u2776er • Register now! • Grads elect officers • Yes we can gang didn\u27t • NFC forecast • MAC report • F & M stings Bears 35 - 21https://digitalcommons.ursinus.edu/weekly/1041/thumbnail.jp
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