Newsletter | May 2, 2019

05.02.19 -- Change Impact Assessments: Fix The Problem Without Breaking Everything Else

Featured Editorial
Change Impact Assessments: How To Fix Something Without Breaking Everything Else
By Alan M. Golden, Design Quality Consultants

It is critical that companies in the medical device space have comprehensive, well-written, and descriptive procedures not only for documentation, but for assessing the impact of any and all changes, no matter how minor.

Industry Insights
How Collaborative Ideation Leads To Advanced In Vitro Diagnostics
Article | By Jo-Ann Loh, KMC Systems

Correctly facilitated collaboration and ideation sessions can be used to generate a surplus of innovative concepts for creating a one-of-a-kind, automated medical device. This blog offers key insights on the KMC Systems’ ideation process and how to implement these ideas into each brainstorming session.

OEMs: Do You Trust Your Medical Device Supplier’s Quality?
Article | By Leo Gelera, Flexan

As an OEM, it is your responsibility to ensure the parts supplied to you are compliant with ISO regulations. Ideally, your supplier’s quality systems are strong enough to identify risks, prevent defects, and to catch defects quickly if they do occur. This requires a robust quality management system. 

Your Complete Outsourcing Partner: Expertise To Turn Your Ideas Into Reality
Article | B. Braun OEM Division

There are OEM suppliers, then there is B. Braun’s OEM Division. B. Braun delivers both a wealth of products and a comprehensive suite of services. They can help you with packaging, sterilization, and regulatory compliance as an OEM partner in the most complete sense of the word. 

How Modeling And Simulating Medical Devices Can Improve Safety And Speed To Market
Article | By Arieh Halpern, Dassault Systemes Americas

Computational modeling and simulation (CM&S) lets you create and simulate human biologic test environments and conditions to complement the validation of safety and effectiveness by nonphysical means.

Building Quality And Precision Into DC Motors Is More Than A Process
White Paper | By Carolyn Mathas, Canon USA, Inc. Optoelectronic Components

Too often the words quality and precision are tossed around indiscriminately. What do they actually mean describing a manufacturer’s reputation to produce and deliver products? Is it the design or manufacturing process that ensures quality? Is it having products that seldom fail? 

How Ultra-Thin Glass Fibers Help Doctors Spot Ailments And Save Lives
Article | SCHOTT North America, Inc. - Lighting and Imaging

Finding a balance between highly specialized instruments and patient well-being raises challenges for the manufacturers developing preventative care tools. Endoscopes equipped with lighting and imaging bundles can help doctors and patients catch health problems early.

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