News » Compliance-consultants
Browse All Categories
By Henry Macartney on June 23, 2020

Are you sure your IT infrastructures are fully qualified, or is it possible that your methodologies missed some vital detail along the way? Perhaps you know you're good at maintaining infrastructure compliance, but your organization is about to reach its operational limits. Either way, it's time for a serious change.

By James Francum
on August 14, 2014

Not sure which pen to use? Although it seems like an amusing topic, your choice of writing utensil actually does make a difference when you're dealing with FDA documentation.

By James Francum
on March 10, 2014

The European Medical Device Directive or 93/42/EEC regulates which medical devices may be sold in the European market, while 21 CFR 820 is an FDA Quality Systems Regulation is a document that helps manufacturers of medical devices establish and follow a quality system within their company / organization in order to ensure that their manufacturing processes and the resultant products consistently meet and fulfill their applicable requirements and specifications. The 21 CFR 820 (also known as the FDA’s Quality System Regulation (QSR)) determines the cGMP requirements for medical devices.