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Medical Device Engineering

Leading Medical Device Company Achieves Major Efficiency Boost by Utilizing SPK’s SolidWorks CSV Expertise

Background Apublicly traded medical device manufacturer with 33,000 employees and several international locations approached SPK and Associates for assistance in streamlining their validation processes. The validation process took months, but the customer wanted...

Accelerating Product Releases with Business Process Automation

The beauty of business process automation How often have we entered the same information into two different systems and wondered, “Why do I have to waste my time doing this?”  These are computers, aren’t they?  Shouldn’t this information flow where it needs to go? ...
ROHS 2 for Medical Devices: Are You Ready?

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 marking must also be RoHS-compliant. ROHS 2 Compliance Changes at...

The FDA UDI Rule: 5 Things You Need to Know

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 requiring medical device manufacturers to label their products with...

FDA Form 483: Top Ten Observations for Medical Devices

FDA Form 483: Top Ten Observations for Medical Devices

Medical Device manufacturers regulated by the FDA are subject to cGMP (Current Good Manufacturing Practice) regulations and may be inspected by the FDA to ensure compliance. If the FDA inspector(s) observes conditions that in their judgment may constitute violations,...

PLM: Automate your Product Development Compliance Process

PLM: Automate your Product Development Compliance Process

Developing new and innovative products is essential for companies to survive and thrive -- however safety can never take a backseat to innovation. That is why many companies, like those in the Medical Devices, Aeronautics and Automotive industries, have strict...

How PLM Enables Innovation Without Risking Compliance

How PLM Enables Innovation Without Risking Compliance

As technology has advanced, it's become more complex -- and with complexity comes the issue of tracking and monitoring the different processes and their corresponding data. In non-critical applications, the extent of this reporting is often minimal. However, in...