Regulatory & Cybersecurity

We know FDA, CE, and CFDA

Cybersecurity

CSK experts on staff, and solutions to help you make sure your device is secure. Medical device vulnerability is a result of modern medical devices becoming more connected. 

With long life-cycles and critical nature, medical devices are particularly prone to cyber attacks. It is crucial for every device, from Class III implantable devices to simple analytical equipment, to have a solid Cybersecurity plan from the beginning. Security should not be bolted on later.

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CSK has leveraged industry standard security designs from the cloud and financial industries and incorporated them into prebuilt C2 Framework for medical devices. The designs include: private/public key infrastructure, TLS encryption, easy certificate revocation in case of a breach, etc.

Verification and Validation

We have years of expertise in FDA and IEC 13485, IEC14971 and IEC62304 regulatory requirements, and can help you get through your 510(k), PMA, CE mark and CFDA submission.

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CSK can help you to develop and execute Verification and Validation plan for your medical system. As needed for your submission, we can develop your test plan, generate robust test cases, execute testing, and provide the resultant reports and trace matrix. We go much further than basic requirements to ensure your device is ready for market. 

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With C2 Framework, we can provide test automation, with fault insertion, internal data monitoring and robust component testing. Our testing is tough on your system in the lab, so you can be confident that surprises will not occur in the field.

Documentation

CSK can help you to develop the technical documentation necessary for your IDE, 510(k), PMA, CE mark and CFDA submission as part of our development services. Our controlled processes are fully FDA and ISO13485 compliant. Whether you are doing development with us or just need help with your submission, let our software regulatory expertise aid you in navigating through the process.