Overview

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Emerging trends and their significance

ISO 9001 is facing its next revision. The focus of the discussions and the approach to the actual co
Aug 19, 2025

Energy management - Are you obligated?

There are a number of legal requirements around the topics of climate and energy management, the ful
Jul 18, 2025

FDA Submissions & ISO 13485: QMS for 510(k), De Novo & PMA

In the U.S, medical devices are regulated under a risk-based classification system established in 21
Jul 16, 2025

Harmonised Standards for Medical Devices

What are harmonised standards?According to Regulation (EU) No 1025/2012, a ‘harmonised standard’
Jul 11, 2025

Certification of Renewable Fuels of Non-Biogenic Origin (RFNBOs)

The transition to a low-carbon economy is one of the key challenges of our time. Renewable fuels of
Jul 03, 2025

What is the IED 2.0 and what has changed?

With the new Directive (EU) 2024/1785 of April 24, 2024, the EU has fundamentally revised the existi
Jun 18, 2025

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