Medical Devices | Testing & Certification

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.

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.

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.

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.