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Medical Devices

Following the evolution of technology in all fields of application, Functional Safety has become a critically important issue across all areas of industry, from transportation, healthcare and medical devices to the design of power plants or amusement parks and rides. As a result, manufacturers and operators place top priority on the quality and safety of products, to protect people, properties and the environment from technology-related risk.

As new applications develop and become increasingly interconnected, the landscape of standardisation is changing, and medical devices are among the most heavily regulated products in the world, as faults can have serious consequences for patients and users. Consequently, ensuring the functional safety of medical devices is critically important for designers and manufacturers as it can impact the health and well-being of the operators that use them and patients that rely on them. Regulations and standards therefore lay down a great number of requirements that can only be fulfilled by applying the principles and methods of functional safety.

Functional safety is part of the overall safety of a system or piece of equipment and uses a systemic approach to identify potentially dangerous conditions or events that might result in an accident that causes harm to the persons interacting with the device. Effective functional safety of electrical and electronic medical devices and systems means that they have built-in safety mechanisms that activate to reduce potential risks to a tolerable level, thereby enabling corrective or preventive actions to avoid or reduce the impact of an accident.

By undertaking risk analysis and manufacturing medical devices that are functionally safe, a manufacturer will benefit from increased market acceptance and positive brand associations. Failure to ensure functional safety can have dire consequences for end users and the corporate reputation of the business selling faulty goods.

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We provide consulting, assessment, cybersecurity, alarm management, product testing and certification under a number of Functional Safety, Security and SW Quality standards, such as IEC 61508, IEC 61511, ISO 26262, ISO 13849, IEC 62061, ISA Security Compliance Institute (ISCI), ASPICE


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