Cybersecurity for medical devices is vital for protecting both the data and lives of patients as well as protecting medical institutions from ransomware attacks. With the evolution of medical devices and their connectivity, cyberthreats have continued to evolve in tandem creating new risks.
The risks in medical device cybersecurity are multifaceted, emphasising the need for up-to-date certifications and standards as well as undergoing cybersecurity evaluations. Effective risk management involves enhancing life cycle processes and conducting rigorous penetration testing to identify vulnerabilities and strengthen security.
The cybersecurity risks for medical devices are:
Given the risks involved, medical device cybersecurity is tested against stringent international and national standards. Regulatory bodies around the world have published guidelines concerning the regulation of medical device cybersecurity and outline the tests that they need to undergo to reach markets. At Applus+ Laboratories, we can support you with the following standards:
Applus+ Laboratories offers comprehensive cybersecurity testing services for evaluating medical devices and we have many years of experience doing cybersecurity evaluations and carrying out penetration tests on all kinds of Targets of Evaluation (TOEs).
Applus+ Laboratories offers extensive penetration testing services to assess the resilience of systems against attacks and unauthorised access. By performing cyberattack simulations, we evaluate vulnerabilities in medical devices across various components:
Our expertise in cybersecurity further enhances the security measures we recommend. Penetration testing activities conducted in our expert lab not only help to strengthen product cyber resilience. The report generated by Applus+ Laboratories experts can be used as a proof of compliance with cybersecurity requirements mandated by regulatory bodies worldwide such as FDA in the USA.
Our teams can also support manufacturers worldwide verifying if their product complies with specific standards or guidelines requested by regulatory bodies. Our certificate of compliance facilitates product readiness for the approval process on various markets.
Contact Applus+ Laboratories to test and certify the cybersecurity of your medical devices to get your product to market as quickly as possible.
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