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This course is designed to familiarize quality and regulatory professionals, engineers, designers and management with the requirements for internal auditing of ISO 13485 quality systems. The objective of this course is to provide the skills and knowledge required to conduct internal audits as required by ISO 13485 and Medical Device Regulation.

On February 11, 2026, SGS will publish its 2025 full year results.

Publication: 6:30am CET, Webcast: 10:00am CET

On March 26, 2026, SGS will hold its Annual General Meeting of shareholders.

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

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.

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.