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 focussing 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 minimise 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 wellbeing 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.
Having developed the first functional safety certification programme for professionals in the process industry over 10 years ago, TÜV SÜD is a pioneer in functional safety services. We are one of the few third-party conformity assessment bodies with functional safety experts for medical devices who can provide functional safety tests.
Our functional safety testing assessment services
Functional safety should be addressed at an early stage to avoid costly rework. TÜV SÜD excels in this area, providing unrivalled testing for functional safety assessment services from the onset.
- Independent safety assessment (ISA) - TÜV SÜD’s team of experts can test the functional safety concept of a medical device after it is prototyped and before implementation of routine production. 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 programme emphasises 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.
Why choose TÜV SÜD?
Our experts preside on standardisation 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 400 dedicated Medical and Health Services (MHS) 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.