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.

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.

Fact Sheets & White Papers

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IEC 62443

Overview of IEC 62443 and our services.

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Common Criteria Fact Sheet

Overview of Common Criteria and our services.

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Medical Devices Security Testing and Certification

Overview of our security testing & certification services for medical devices.

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Common Criteria Implementation Guide

Key concepts of Common Criteria and Requirements.

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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.

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Related Services & Training Courses

Common Criteria

Medical Devices  - Testing & Certification

Discover what Secura's Common Criteria services can do for you. The Common Criteria certificate is automatically recognized in a wide range of countries, spread across multiple continents, like EU, USA, Australia, UK and parts of Asia.

IEC62443 Training

Security organization training courses

This training provides you with an overview of the IEC62443 series of standards. It presents the main cybersecurity concepts in industrial security and includes an overview of all the requirements contained in IEC62443.

Why choose Secura | Bureau Veritas

At Secura/Bureau Veritas, we are dedicated to being your trusted partner in cybersecurity. We go beyond quick fixes and isolated services. Our integrated approach makes sure that every aspect of your company or organization is cyber resilient, from your technology to your processes and your people.

Secura is the cybersecurity division of Bureau Veritas, specialized in testing, inspection and certification. Bureau Veritas was founded in 1828, has over 80.000 employees and is active in 140 countries.