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Compliance & Regulatory

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...

Enhancing Traceability and Compliance with PTC Windchill

Enhancing Traceability and Compliance with PTC Windchill

As complex, smart, and connected products become the norm, manufacturers must contend with increasingly stringent regulations. Traceability and compliance are mission-critical. Manufacturers must also meet rising customer expectations and overcome unpredictable supply...

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...