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Author: <span class="vcard">admin</span>

Presumption of Conformity Route or Not Under the MDR?

July 18, 2020 admin Leave a comment

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Emergency Stop Switch per MDR ANNEX XVI Common Specifications Annex 1 to 6

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Containment Action in CAPA

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90% of Manufacturers Fall Short in Product Safety Certification

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CE Marking Directives Plus MDR

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General Rules for Software Validation

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What is a Medical-Grade Power Supply?

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Lost in the Regulatory Uncertainties?

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Did you know? We have experience in Automated Guided Vehicles (AGVs) and Robots

February 26, 2020 admin Leave a comment

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Exercising the route to compliance by use of harmonized standards as “Presumption of Conformity”.

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Exercising the route to compliance by use of harmonized standards as “Presumption of Conformity”. For many, this is the default choice…

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