This article reviews what an FDA 483 Observation looks like, some of the more common issues flagged in medical device companies, and how to respond.
Cloud
Hybrid Cloud Implementation Pitfalls Your Small Business Needs to Avoid
If you’re like many SMBs, IT infrastructure is not your favorite topic. You think about it when you have to, which means that it often becomes neglected, lagging behind other capital investments. What’s more, there’s a good chance your current IT  solutions are...
Podcast Series: Can IoT Jump These Five Hurdles? – Episode 1: Introduction
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How PLM Companies Can Stop Marketing Cloud Technology and Start Deploying New User Experiences
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 deploying new user experiences in the cloud. SPK and Associates...
Five Hybrid Cloud Implementation Pitfalls an SMB can Avoid
You likely know your company's IT infrastructure must be upgraded soon. However, you may be avoiding it due to perceived cost or difficulty. The good news is that you don’t have to make large capital expenditures to expand and update your IT infrastructure. Hybrid...
Increasing Engineering Productivity and Profitability via a True Cloud-Based SolidWorks/PDM Implementation
How SPK was able to unify globally dispersed engineering teams to work, and communicate, in real-time. THE CLIENTA leading medical device manufacturer was facing a problem common to firms with growing engineering operations: As their product-development team grew,...