The lack of a “medical grade” for electronic components forces medical device manufacturers to either take the risk of using standard electronic components, which may pose reliability issues, or accept being constrained by their suppliers’ component choices, which can create economic risks.

Through the RECOME project, our teams aim to develop an extensive database of qualified components suited to medical applications, thereby securing the supply chain by increasing component availability and facilitating the search for equivalencies.

Electronics are increasingly integrated into implanted medical devices, necessitating enhanced reliability. Any failure in the electronics can have an immediate impact on the patient, such as requiring emergency surgery or even resulting in death.

Unlike other industries, such as aerospace, space exploration, or nuclear energy, where reliability is achieved through high levels of redundancy, medical devices—especially implantable ones—must occupy a small volume, severely limiting the possibility of system redundancy. As a result, the overall reliability is directly linked to the reliability of the device’s components.

Component selection is a critical factor in determining your product’s reliability. If a component is unsuitable, the risk of failure or malfunction during use increases significantly. Careful selection of components is of utmost importance.

Additionally, estimating and demonstrating the reliability of electronic components are essential considerations for obtaining market authorization and ensuring safe use of the medical device.

These solutions provide assurance of quality and reliability for your electronics, ensuring that all potential risks over time are accounted for.