Cybersecurity is crucial for internet-connected medical devices and hospital networks, aiming for high efficiency and advanced services. Yet, this connectivity elevates cybersecurity risks. Globally, regulators now require resilience against these threats for medical devices, prompting stricter regulations and mandatory cybersecurity assessments.

Why choose SGS product security evaluation services for medical devices?

We enable you to:

• Comply with regulations and corresponding standards
• Generate evidence and proof that cybersecurity-related risks have been considered, evaluated, and mitigated for the complete lifecycle of devices, systems, and networks
• Gain specialized training, assessment, and certification with a special focus on the intertwined relationship of cybersecurity and functional safety
• Obtain comprehensive testing for medical devices – from particle testing to software, electrical, and cybersecurity testing

Medical device cybersecurity pre-assessment

Our medical device cybersecurity pre-assessments include:

• Cybersecurity threat and risk analysis for medical devices
• Security capability maturity assessments for organizations and business processes
• Security-related gap assessments and design reviews for medical devices covering the complete product life cycle
• Review and assessment of applied cybersecurity risk management for medical devices (e.g., according to AAMI TIR 57)
• Vulnerability assessments for hardware and software, as well as network and cloud solutions
• Customized security assessment and test campaigns in preparation for product approvals (e.g., FDA 510k application) and against relevant standards
• SBOM scanning

Medical device cybersecurity evaluation for formal certification

We provide medical device cybersecurity evaluation for formal certification, such as:

• Independent conformity assessments against cybersecurity guidance documents issued by the US FDA or issued in connection to the European MDR/IVDR regulations
• Independent security-related conformity assessments against the standards DTSec, IEC81001-5-1, ISO60601-4-5, AAMI TIR57, AAMI TIR97, AAMI SW96.
• Security evaluation according to the BSZ Certification Scheme governed by the BSI in Germany
• Security evaluation according to the SESIP scheme is suitable for IoT devices governed by GlobalPlatform

To discover your cybersecurity medical devices' requirements, contact us today.