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Medical Device Engineering

How Cloud-Based CAD Is Changing the Future of Collaborative Design

How Cloud-Based CAD Is Changing the Future of Collaborative Design

Traditional desktop-based CAD tools, while powerful, can have a hard time meeting the growing demands of modern engineering teams. They need better connectivity, scalability, and flexibility. That’s why cloud-based CAD (Computer-Aided Design) is quickly becoming the...

3 Top Trends in Product Lifecycle Engineering Tools

3 Top Trends in Product Lifecycle Engineering Tools

Overview In 2015, SPK and Associates co-founder Chris McHale spoke with Peter Thorne, Director at Cambashi, a Cambridge, England-based independent industry analyst firm. With his over 30 years of experience as a software engineer user, vendor, and now analyst, Peter’s...

Accelerating Product Development the SPK Way

Accelerating Product Development the SPK Way

Developing high-quality products quickly can be a challenge without the proper tools, processes, and partners to help. Dive into this eBook to discover how partnering with SPK can help you achieve product development success.What You Will Learn In this eBook, we will...

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,...