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 Organisation 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 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 throughout your product development cycle - from concept to final production.
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.
TÜV SÜD developed the world’s first functional safety certification programme 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 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 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.
How to ensure a smooth transition to MDR certification.