MEDICAL DEVICES | FDA & MDR regulations

Medical Cybersecurity: The essential regulatory framework for ensuring the reliability of connected devices

The healthcare sector and its associated infrastructure are among the most critical in every country. Medical devices that allow direct interaction with patients must have state-of-the-art performance features. At the same time, the rapid increase in cybersecurity threats and attack vectors is increasingly impacting medical devices.

From a cybersecurity perspective, most of these devices are high-risk targets. Controlling and minimizing these risks therefore becomes a very important process that manufacturers must take into account..

TAKING SAFETY INTO ACCOUNT THROUGHOUT THE DEVELOPMENT AND MANUFACTURING PROCESS OF MEDICAL DEVICES CAN BE AN EFFECTIVE WAY TO PREVENT FUTURE SAFETY BREACHES AND THUS STRENGTHEN BRAND IMAGE AND REPUTATION.

Furthermore, due to the high risks associated in practice with their devices, medical device manufacturers must comply with certain regulations in order to place their products on specific markets.
Aux États-Unis, la "Food and Drug Administration" (FDA) is the institution responsible for monitoring food and medicines and regulating market access, while in the EU it is the MDR (Medical Device Regulation), the regulation on medical devices (2017/745/EU) adopted in May 2017 which governs it.

Evaluating, demonstrating conformity, or obtaining relevant safety certifications for your medical devices are important steps to improve their safety, gain access to specific markets, and highlight their value to patients or healthcare facilities. The LCIE can assist you with several testing and certification options.