Newsletter | February 18, 2021

02.18.21 -- An ISO 14155:2020 Primer -- Good Clinical Practice For Medical Device Trials

 
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Industry Insights
Choosing A CMO: Find The Best Match By Asking The Right Questions

When selecting a CMO, it’s important to look at organizational alignment, senior leadership engagement, program management, commitment to projects large and small, and processes in place to manage risk. 

Automation: The Future Of Medical Device Manufacturing

The expectation for zero defects in medical devices is higher than ever. Manufacturers must find ways to achieve that expectation while reducing costs and risks. This article explains how automation can help manufacturers reach those goals.

Integrating Human Factors Into The Product Development Process – BD Intevia 1 mL Two-Step Disposable Autoinjector

At BD, human factors activities are conducted throughout the phase-gated product development process. For the BD Intevia 1 mL autoinjector, nine studies focusing on the device/user interface were conducted over the course of the project to identify and to eliminate or reduce the risk of error so the device can be used safely.

Design For Manufacturing Breakthroughs: Producing Innovative Medical Microdevices

MTD offers tips and specific questions to ask when designing and producing medical microdevices. This white paper walks through considerations for popular and new material choices, application requirements, costs, production challenges, and more.

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