Medical Devices | Testing & Certification
Have your medical devices tested and certified against international cybersecurity standards like IEC 62443, UL 2900 and Common Criteria with Secura's IoT cybersecurity services. Contact us today.
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Testing & Certification of Medical Devices
Modern medical devices are high-risk targets from a cybersecurity perspective. They are often connected to a network, and have critical implications for human lives.
To place your medical devices in specific markets, compliance with regulations is mandatory. Let Secura help you enhance the security of your products and strengthen your position in the market.
Secura has extensive experience in the interpretation and practical applicability of the internationally recognized IEC 62443 standard. Several parts of this standard can be of value to highlight the security of the product or development processes. IEC 62443-4-2 and IEC 62443-3-3 can be used to validate the security of medical products or integrated systems. IEC 62443-4-1 can be used to validate the security of the medical devices development processes.
Secura Medical Devices Security Framework
In order to provide a flexible approach to the manufacturers, Secura has developed its own testing framework, based on state of the art security guidelines such IEC 62443, UL 2900 or the ENISA Security Baseline Recommendations. Testing your product against the requirements of the framework allows manufacturers to select the depth of testing, thus perfectly addressing their needs.
Secura IoT Security Framework
In order to provide a flexible approach to the manufacturers, Secura has developed its own testing framework, based on state of the art security guidelines such as IoT security Foundation, IEC 62443, GSMA or OWASP. Testing your product against the requirements of the framework allows manufacturers to select the depth of testing, thus perfectly addressing their needs.
Certification allows to put official recognition on the results of an assessment for your product. Secura can support you with certification services for your IoT product based on the following schemes.
Secura can support with official certification of medication devices in line with the UL 2900 (-2-1) standard, issued by Bureau Veritas. The service will result in a certificate that demonstrates the compliance of the product with the applicable requirements. This certificate can facilitate market access, being especially well recognized for FDA Cybersecurity compliance.
Common Criteria is an internationally recognized security assessment and certification methodology. Common Criteria certificates are mutually recognized across continents, including most of EU, USA, Asia, Australia, UK, etc.
Secura can support with Common Criteria evaluations, under the Dutch Common Criteria scheme NSCIB.
How we support you
Secura helps large and medium sized organizations all over Europe raise their cyber resilience. We know the importance of testing and certification of medical devices. Secura is part of the Bureau Veritas Group, a listed company and world leader in testing, inspection and certification services.
Fact Sheets & White Papers
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Related Services & Training Courses
Secura is a leading cybersecurity expert. Our customers range from government and healthcare to finance and industry worldwide. Secura offers technical services, such as vulnerability assessments, penetration testing and red teaming. We also provide certification for IoT and industrial environments, as well as audits, forensic services and awareness training. Our goal is to raise your cyber resilience.
Secura is a Bureau Veritas company. Bureau Veritas (BV) is a publicly listed company specialized in testing, inspection and certification. BV was founded in 1828, has over 80.000 employees and is active in 140 countries. Secura is the cornerstone of the cybersecurity strategy of Bureau Veritas.