Newsletter | February 11, 2021

02.11.21 -- With Release Of New Guidance Document, FDA Launches Safer Technologies Program for Medical Devices

 
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The Market For 3D Printed Bioresorbable CMF Plates And Other Complex Devices Is Being Redefined By New GMP-Grade Filament Material

The adoption of 3D printing technologies for implantable medical devices has been relatively slow and largely confined to metal-based implants traditionally used for hip, knee, and spine reconstruction applications. This has been due to challenges in sourcing the right biocompatible materials, validating processes, and adhering to quality and regulatory requirements.

UV Sterilization: Eliminating Bacteria Using Advanced LED Technology

UV radiation is the only sterilant that directly destroys the DNA of bacteria and other contaminants. Hermetically sealed LEDs provide a viable alternative to conventional UV technologies.

The Benefits Of Aqueous Critical Cleaning In Pharmaceutical Manufacturing

The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of efficacy, minimal surface contact, reduced residue potential, and easier cleaning validation.

The Only Validation Approach That Gets — And Keeps — Your Molded Part In Spec

When subcontracting medical or optic injection molded components, do you carefully evaluate your molder’s validation process? There is only one approach that is proven to keep your molded parts “in spec”: decoupled molding.

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