Our Product Security Assessment offering provides a comprehensive evaluation of your organization's product security practices, technical measures, and regulatory submissions.
Through process and technical assessments, we identify gaps and provide valuable insights to enhance your overall product security posture.
Our Regulatory Submission Review service ensures the completeness and compliance of your FDA submission package by conducting a thorough assessment of cybersecurity activities and documentation, minimizing the risk of delays or rejections.
Product Security Process Assessment
Strengthen your organization's product security processes with our comprehensive Product Security Process Assessment. We evaluate your processes against industry guidance documents and standards, including FDA Guidance, MDCG, HealthCanada, Australia TGA, IMDRF, and more, ensuring strong and compliant security practices.
Product Security Technical Assessment
Safeguard your product against evolving cyber threats with our Technical Product Security Assessment. We conduct a thorough evaluation of your product's security measures, benchmarked against industry standards such as NIST 800-53r5, providing valuable insights to enhance its security posture.
Product Security Regulatory Submission Review
Prior to submitting to the FDA, our Regulatory Submission Review service conducts a thorough assessment of your FDA submission package, specifically focusing on cybersecurity activities and documentation. We meticulously review the package to ensure all required cybersecurity measures have been implemented and the documentation is in order. With our comprehensive review process, you can have confidence in the completeness and compliance of your submission, minimizing the risk of delays or rejections from the FDA.