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.
> IoT | Testing & Certification > Medical Devices
Testing & Compliance 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.
IEC 62443 assessment |
Secura has extensive experience in the interpretation and practical applicability of the internationally recognized IEC 62443 standard. IEC 62443 is one of the recognized standards for medical devices security compliance, being especially valuable in the context of regulatory access such as EU MDR or US FDA approval. |
UL 2900 assessment |
As a recognized UL 2900 certification body, Secura can support with UL 2900 preparatory services, such as code review, product documentation review or penetration testing |
Medical devices penetration testing and code reviews |
Secura can provide independent security assessment services for medical devices, such as penetration testing, validation or penetration testing. |
Medical Devices Certification
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.
UL 2900 certification |
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 |
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.
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More Information
Are you interested in our Testing and Certification Services for Medical Devices? Please fill out the form below and we will contact you within one business day.
Related Services & Training Courses
Common Criteria
ABOUT SECURA
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.