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 & 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.

IEC 62443

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

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

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

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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

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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.

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.