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Medical Software - ISO 13485 and IEC 62304 as Part of the Development Process

The importance of software in connection with electrically powered medical devices or as an independent product has grown significantly. The change has caused that more and more often the assessment of the patient's condition and the decision to treat or not to treat is based on the results calculated by the software. The use of software in medical devices obliges the manufacturer to demonstrate that the software is safe, compliant and high-performance. There are also requirements for the software development, usability and risk management process used to design the product.
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Wireless Network and Connection Technology Concept

IoT Tech Expo 2026

Meet our product testing and compliance experts at this premier event for connected technologies.
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Connectivity Battery Energy Storage

IEEE ISPCE 2026

Join us at the world’s leading product compliance engineering conference for expert insights into electrical and electronic regulatory compliance.
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Argus Europe Carbon Conference 2026

SGS will join the Argus Europe Carbon Conference 2026 in Nice to share expertise on CBAM, carbon markets and emerging EU decarbonisation frameworks.
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GrainCom26

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IVDR_Scientist Making Experiment in Laboratory

IVDR - From Fundamentals to Technical Documentation

For many organizations, the transition from IVDD to IVDR has proven to be challenging—particularly in the areas of technical documentation, clinical evidence, and risk management. For manufacturers of new devices, this is also highly important, as devices must comply with IVDR requirements before being placed on the market.

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Various pharmaceuticals pills capsules tablets softgel of food supplements, fish oil, vitamin omega

Vitafoods Europe 2026

SGS will exhibit at Vitafoods Europe 2025, showcasing our comprehensive testing, certification and regulatory solutions for nutraceutical brands.
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Offshore Oil Platform

Offshore Technology Conference (OTC) 2026

Come and meet our experts at the Offshore Technology Conference (OTC), one of the world’s premier events for the offshore energy industry.
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Doctors examining

Medical-Device Usability – IEC 62366-1 as part of the development process

The importance of usability in electrical and medical devices has grown dramatically. Good usability improves efficiency safety for medical device functionality and satisfaction with device use. Usability is also linked to demonstrating medical device compliance. Some of these requirements involve extensive documentation and a range of practical testing and specifications. This training will cover the usability process, specifically to the requirements of IEC 62366-1, but will also open up the design process from the perspectives of ISO 13485, IEC 60601-1-6 and ISO 14971 in the MDR/IVDR environment.
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SGS 2026 Q1 Banner

SGS First Quarter 2026 Sales Update

On April 23, 2026, SGS will publish its first quarter sales update.
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