The healthcare industry is one of the most critical infrastructures in each country, due to its direct implication on humans. Medical devices providing direct interaction with the patients need to be equipped with state-of-the-art features in terms of performance. At the same time, the fast rise of cybersecurity threats and attack vectors is impacting medical devices more and more.
From a cybersecurity point of view, most of these devices are high risk targets. Controlling and minimizing these risks becomes therefore a highly important process which manufacturers need to take into account.
Taking security into consideration during the whole development and manufacturing process of the medical devices could represent a strong means for avoiding any future security breaches, thus consolidating the brand’s image and reputation.
Moreover, due to the high risks associated in practice with their devices, medical device manufacturers need to comply with certain regulations in order to place their products on specific markets. In U.S.A, the Food and Drug Association (FDA) is regulating the market access, while in the EU, medical devices need to fulfill the Medical Devices Regulation.
Assessing, demonstrating compliance or obtaining relevant security certifications for your medical devices are important actions in order to improve their security, obtain the clearance for specific markets, and ultimately showcase their value to the patients or healthcare institutions. LCIE can support you with several testing and certification possibilities.
Cybersecurity: how to link the Medical Devices Regulation with the UL 2900 standard?