May 12, 2017

New MEDDEV Guidelines: What You Need to Know

In July 2016, revision 4 of the MEDDEV 2.7/1 guidelines was released to much anticipation within the medical device community. The document has been expanded and now contains expanded details on requirements that effect almost every aspect of the clinical evaluation of medical devices with CE-mark. So what do you need to know to make sure your organization is in compliance? (more…)

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