Medical Devices | Testing & Certification

Bureau Veritas Cybersecurity 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. We can support you with the evaluation and certification of your medical products and security processes based on IEC 62443.

As a recognized UL 2900 certification body, Bureau Veritas Cybersecurity can support you with UL 2900 preparation, all the way to the formal evaluation and certification. 

IEC 81001-5-1 is a standard that focuses on cybersecurity aspects of medical devices software.

Bureau Veritas Cybersecurity can support you with IEC 81001-5-1 preparation, all the way to the formal evaluation and certification. 

Bureau Veritas Cybersecurity can provide independent security assessment services for medical devices, such as penetration testing, validation or penetration testing. 

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.

Bureau Veritas Cybersecurity can support with Common Criteria evaluations, including the latest EU CC scheme.

Bureau Veritas Cybersecurity can support you along the way for your EU MDR and US FDA regulatory compliance. Our services include training for these regulations, as well as support and gap analysis services. Certification of your medical devices products in line with standards such as UL 2900, IEC 62443 or Common Criteria can also help strongly in the regulatory compliance.