Cybersecurity_MedicalDevices

CYBERSECURITY SERVICES
for Medical Devices

Medical devices are one of the most high-risk type of products, due to their direct use in human health or vital functions.

YOUR CHALLENGE

Due to this important aspect, such devices need to pass extensive regulations and certifications programs, which are aimed to validate their clinical performance. Recent security vulnerabilities which were exploited in practice on some medical devices (such as for example pacemakers) raised the awareness of the importance of cybersecurity.

In response, most of the regulatory initiatives have added cybersecurity to the list of requirements that need to be addressed by the manufacturers. Such requirements address both the processes behind the development of the product, as well as testing and validation of the implemented security features.

HOW BV CAN HELP

Bureau Veritas can support medical device manufacturers with the regulatory compliance for US and/or EU, as well as testing and certification based on the most relevant international standards.

Medical Devices Regulations Certification

Medical devices are among the products with the most extensive set of regulations regarding local market access. For both the EU and USA, but also many other regions and countries, local regulations need to be satisfied by the developers. While these regulations historically focused on the clinical performance of the products, recent updates to the FDA and EU MDR have introduced specific requirements linked to cybersecurity. Developers are required to compile an evidence file aimed to demonstrate compliance with these requirements. The requirements include compliance with development processes, risk assessment, but also state of the art security controls (using standards such as ANSI UL 2900 and IEC 62443 as reference) and evidence of conducted testing.

Bureau Veritas can support manufacturers of medical devices with testing and certification of their products based on ANSI UL 2900 and IEC 62443. At the same time, support can be given for identifying compliance gaps with the FDA and EU MDR regulations, as well as consultancy in closing these gaps.

OUR CAPABILITIES

Support and Preparation

- Design Reviews
- Validation and Penetration Testing
- Code Reviews
- Processes Reviews

Compliance and Testing

- IEC 62443 Compliance
- UL 2900 Compliance

Certification/Regulatory

- UL 2900 Certification
- Common Criteria Certification
- EU MDR Compliance Gap Analysis
- FDA Compliance Gap Analysis

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