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The FDA UDI Rule: 5 Things You Need to Know
The release of the FDA final rule on Unique Device Identification (UDI) is expected this summer. Here are five things you need to know: 1. What is the UDI Rule? In July 2012, the FDA proposed a rule...
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ROHS 2 for Medical Devices: Are You Ready?
As of July 22, 2014, the RoHS (Restriction of Hazardous Substances) Directive must be observed for first time distribution of all medical devices to the full extent. Furthermore, all products with a CE...
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PLM in the Cloud: Computer System Validation in FDA Regulated Industries
Product lifecycle management (PLM) systems have evolved from being custom-built, on-premise applications to cloud-based, off-the-shelf solutions. As adoption for PLM in the cloud increases, system...
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Medical Device Interoperability: A $30B opportunity?
Greater medical device interoperability and the adoption of commonly accepted standards could save the US in excess of $30B, suggests a West Health Institute report published in March. Lack of device...
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4 Hardware Recommendations when Using VMs as a Product Development Tool
These days, there is no practical obstacle to using machine virtualization to solve computing problems without the need of acquiring additional hardware. In fact, virtual machines are a compelling...
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MKSSI Environment Variable – an Integrity PLM Software Primer
I’m not a programmer by trade, so I’ve had to force feed myself a lot of knowledge – some of it makes sense, some of it is beyond me. I’ve written this post to serve as an Integrity PLM Software Primer...
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How-to Run Android 4.4 (KitKat) using VMWare Player
Did you see our guide for running Android 4.0 in VMWare from two years ago? We’ve updated the instructions, below, to help you get the newest version of Android running to use as a product development...
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5 Reasons You Want Your PLM in the Cloud
Put it in the cloud. You’ve heard this catch phrase over and over again, more so in recent years with the proliferation of online technologies and services. As more and more PLM software vendors choose...
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My Arsenal of Product Development Tools
There are so many tools that are available to help make the process of coding more efficient, less time consuming, and overall a better experience. There are a number of tools / configuration settings...
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Medical Device Development: First to Market
In the world of fast competitive marketing, a lot of attention goes to the first company who develops a creative breakthrough and comes out with a cool new device first. New technology in the medical...
View ArticleTop 3 PLM Predictions for 2015
SPK and Associates co-founder Chris McHale recently spoke with PLM expert Oleg Shilovitsky, Sr. Director at Autodesk and founder of BeyondPLM.com, to get his top three product lifecycle management...
View ArticleNew Podcast: Talking Beyond PLM with PLM Expert Oleg Shilovitsky
SPK and Associates co-founder Chris McHale previously spoke with PLM expert Oleg Shilovitsky, founder of BeyondPLM.com, to get his top three product lifecycle management (PLM) predictions for 2015. Now...
View ArticlePodcast: Oleg Shilovitsky Discusses the Difficulty of BOMs Across Engineering...
SPK and Associates co-founder Chris McHale speaks with PLM expert Oleg Shilovitsky, founder of BeyondPLM.com, to get his insight on the difficulty of BOMs across engineering disciplines. The pair will...
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Why Software Builds Fail and Areas for Improvement
In a recently published paper, researchers at Google examined the issue of failed software builds within their organization. Specifically, they wanted to address the separate questions of “How often do...
View ArticlePodcast: Oleg Shilovitsky Discusses the Difficulty BOM’s Across the Product...
Last month, SPK and Associates co-founder Chris McHale spoke with PLM expert Oleg Shilovitsky on the difficulty of BOMs across engineering disciplines. In part two of the discussion, they focus in on...
View ArticlePodcast: Peter Thorne Discusses Hot Trends in Product Lifecycle Engineering...
SPK and Associates co-founder Chris McHale speaks with Peter Thorne, director at Cambashi, a Cambridge, England-based independent industry analyst firm. With his over 30 years of experience as a...
View ArticleHow PLM Companies Can Stop Marketing Cloud Technology and Start Deploying New...
Is PLM in the cloud actually delivering new user experiences? According to PLM expert Oleg Shilovitsky that answer is no. He believes PLM companies need to stop marketing cloud technology and start...
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Today’s Growing IoT Problem: Embedded Software Security – An Interview with...
When it comes to the Internet of Things (IoT) and connectivity, embedded software security is a top concern for a growing number of manufacturing companies and their software engineers. The worldwide...
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SPK Develops Dashboard for E*Trade’s Electric Commander
Why are dashboards important? In a nutshell, they allow you to visually present information in a way that is meaningful to the reader. They allow the reader to immediately see trends, and more...
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Musing the Chasms IoT Must Cross
Every major cloud vendor is offering IoT platforms in varying degrees of maturity now. Device management, performance metrics, messaging, sensor data analytics are becoming systematized and offered in...
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