Date
13 results found
ICPHSO 2025
Join us at ICPHSO 2025 Annual Meeting and Training Symposium for the latest trends and solutions in consumer product safety.
SOCMA Show 2025
Visit SGS at Booth #100 at the SOCMA Show in February 2025.
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ISO 13485 and MDR Internal Auditor
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.
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Lubricant Expo North America 2025
Visit SGS at Booth #133 at the Lubricant Expo North America 2025.
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SGS 2025 Annual General Meeting of Shareholders
On March 26, 2025, SGS will hold its Annual General Meeting of shareholders.
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GFSI Conference 2025
Join SGS at the 2025 GFSI Conference in Dublin, Ireland
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SGS First Quarter 2025 Sales Update
On April 24, 2025, SGS will publish its first quarter sales update.
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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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Medical and IVD Device Risk Management
Risk management is a key factor in assessing the safety of medical devices. MDR and IVDR requirements also require risk management to be taken into account as part of the quality system.
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IEC 60601-1 as part of Medical Device Design and Testing
During the training we will open the content of the IEC 60601-1 series of standards in terms of technical requirements. We review IEC 60601-1 as part of its approvals for different markets. From IEC 60601-1 ed. 3.2, we provide you with an understanding of testing, electrical safety and risk management requirements for medical devices. All of which are key considerations in the design and testing of medical devices.