Case StudyBlood Handling Product Portfolio
About This Project
In light of the latest FDA cybersecurity guidance, a leading blood handling equipment manufacturer sought help in developing and maturing their cybersecurity practice for their broad portfolio of fielded legacy products.
- Challenges
- Approach & Solution
- Outcomes
• Diverse product portfolio, including legacy products with varying degrees of cybersecurity gaps in product design, implementation, and documentation
• New product security team building capabilities, infrastructure, and processes while simultaneously servicing backlog of product-specific demands
• Several planned regulatory submissions with various product teams using different methods and formats for generating required cybersecurity deliverables
• Performed overall portfolio and process assessment
• Reviewed and updated cybersecurity SOPs in accordance with latest FDA guidance and standards
• Provided templates for DHF cybersecurity documents
• Exercised SOPs and utilized templates for prioritized set of products with upcoming submissions
• Drafted and updated documents as needed to address identified gaps
• Provided training on the cybersecurity process and templates
• Significantly matured cybersecurity practice while still addressing product-specific demands
• Cybersecurity documents accepted by FDA and other regulatory bodies as part of timely product clearance decisions
• Alignment across quality, security and product teams, driving consistency and efficiency in the application of cybersecurity best practices