EU

EU Technical Files

EU Technical Files

A concept similar to the FDA’s Design History Files, the EU Technical File is a collection of documents related to the...

EU MDR: Importers

EU MDR: Importers

The new EU MDR 2017/745 is complex, to say the least. Depending on a company’s relationship to the medical device the...

CLIC©: A Self-Learning QMS?

CLIC©: A Self-Learning QMS?

‌  Our clients have extensive experience and familiarity with CLIC, but for many of you out there, it is a new...

Global Handwashing Day

Global Handwashing Day

‌  Founded in 2008, “October 15 is Global Handwashing Day a global advocacy day dedicated to increasing awareness...

Surviving A Recall

Surviving A Recall

‌  Being non-compliant in even a small detail of a regulation can result in the need to perform a recall. For...

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