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Functional Safety Testing of Medical Devices

Undergoing tests is a critical step in the process of transforming an innovative design into a reliable and marketable product

Functional Safety in the Medical Industry

Medical devices are among the most highly regulated products in the world today. A single functional failure can mean the difference between life and death for patients. The World Health Organization has recommended that governments worldwide make national regulations for medical devices an integral part of their overall national health systems.

Traditional safety assessment focuses on potential hazards from electrical, mechanical or other aspects of a design occurring during usage. Functional safety is an additional step focusing on the reliability of the product to function correctly and safely in response to its inputs. It provides assurance that safety-related systems in the device will offer the necessary risk reduction required to minimize the severity and probability of harm in the event of malfunction.

Ensuring the functional safety of medical devices is critically important for manufacturers, importers and resellers, as these devices can impact the health and well-being of the operators and patients that use them.

By undertaking risk analysis and manufacturing medical devices that are functionally safe, your company benefits from increased market acceptance and positive brand associations. Failure to ensure functional safety can have dire consequences.

FAQ - Functional Safety for Medical Devices

Our assessment services

Functional safety should be addressed throughout the product development cycle, particularly in the product’s initial design, to avoid costly rework. Our testing services cover every step of product development.

  • Independent safety assessment (ISA) - TÜV SÜD’s team of experts can test the functional safety concept of a medical device while it is in the design stage, and after it is implemented and prototyped. We also offer ISA on the overall risk management system to determine if it is sufficient for the stringent requirements placed on medical devices.
  • Software safety assessment - A software glitch in sophisticated medical equipment such as MRI and X-Ray machines can have catastrophic consequences for patients and operators. That is why TÜV SÜD’s functional safety program emphasizes the assessment of medical software against safety standards such as IEC 60601 and IEC 62304.
  • Product testing - We also offer electrical safety testing, electromagnetic compatibility testing and environmental testing services for medical devices.

our functional safety expertise

TÜV SÜD developed the world’s first functional safety certification program for professionals in the process industry in 1999. Since then, we have certified more than 1,000 functional safety experts globally and issued more than 2,000 certificates for functionally safety tested products. Our experts preside on standardization committees for functional safety and can inform you about emerging standards and regulations so that you stay ahead of the competition.

In the field of medical devices, TÜV SÜD is the largest Notified Body in the world, having over 700 dedicated medical health and services experts situated in major markets worldwide. In addition, we have a dedicated Regulatory Foreign Affairs & Clinical Department for monitoring and understanding updates in medical health services and devices regulations worldwide.

Your benefits at a glance

  • Cultivate a trusted brand - built upon a line of products known to be functionally safe with fewer incident reports.
  • Reduce cost and time - by minimizing corrective actions in the field as well the costs of re-engineering products with poor functional safety.
  • Gain a competitive edge - by working with our diverse and industry-leading experts, who will provide you with the highest quality reports, keeping you one step ahead of the competition.


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