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Compliance & Regulatory

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...

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,...

Accelerating Medical Software Compliance and Efficiency with SPK ACEs

Accelerating Medical Software Compliance and Efficiency with SPK ACEs

Compliance with regulatory standards is the number one priority for every medical manufacturer.  Ensuring pipelines are secure and compliant doesn’t just ensure safety, but it results in better quality products.  When a startup medical manufacturing company contacted...

7 Steps for Implementing ISO 9001 Quality Systems Successfully

7 Steps for Implementing ISO 9001 Quality Systems Successfully

Implementing a Quality Management System (QMS) that ensures compliance with ISO 9001 is a strategic decision for organizations. Implementing this system enhances customer satisfaction, improves efficiency, and drives continuous improvement. However, achieving ISO 9001...