Apraciti, LLC
Apraciti, LLC specializes in providing comprehensive medical device cybersecurity services tailored specifically for medical device manufacturers. Their expertise in medical devices, medical device data systems, software as a medical device, and product security allows them to offer a range of solutions to fortify the security of products and organizations. They focus on cybersecurity engineering support, regulatory submission support, and integrating cybersecurity with quality management systems, helping clients navigate complex regulatory landscapes and enhance product security.
Industries
Nr. of Employees
small (1-50)
Products
Device FDA Submission (case study)
Project supporting a US FDA submission for a medical device and medical device data system that included threat-modeling workshops, architecture/data flow diagrams, review of SAST and SCA results, CVSS-based risk assessments, and preparation of the regulatory submission package.
Post Market Product Security (case study)
Case study offering post-market security support for deployed medical devices, including vulnerability management and lifecycle security activities.
SaMD FDA Submission (case study)
Case study of regulatory submission support for software-as-a-medical-device including cybersecurity activities required for submission.
SAST and SCA Tool Implementation (case study)
Project implementing static analysis and software composition analysis tooling and processes to identify and manage software vulnerabilities.
Vulnerability Summary Report (case study)
Report summarizing identified vulnerabilities and recommended remediation actions for a product security engagement.
Device FDA Submission (case study)
Project supporting a US FDA submission for a medical device and medical device data system that included threat-modeling workshops, architecture/data flow diagrams, review of SAST and SCA results, CVSS-based risk assessments, and preparation of the regulatory submission package.
Post Market Product Security (case study)
Case study offering post-market security support for deployed medical devices, including vulnerability management and lifecycle security activities.
SaMD FDA Submission (case study)
Case study of regulatory submission support for software-as-a-medical-device including cybersecurity activities required for submission.
SAST and SCA Tool Implementation (case study)
Project implementing static analysis and software composition analysis tooling and processes to identify and manage software vulnerabilities.
Vulnerability Summary Report (case study)
Report summarizing identified vulnerabilities and recommended remediation actions for a product security engagement.
Services
Ongoing engineering support including design reviews, analysis of security testing results, responses to regulatory questions, and support for healthcare organization questionnaires.
Lead and perform cybersecurity activities for regulatory submissions, including architecture/data flow diagrams, threat modeling, requirements documentation, V&V support, labeling inputs, and submission guidance.
Comprehensive evaluations of organizational product security processes and technical controls, including benchmarking against regulatory and standards documents and identification of remediation actions.
Develop processes, work instructions, and templates to integrate cybersecurity into existing quality management systems and update related procedures (design control, risk management, complaint handling).
Deliver threat-modeling training and facilitate interactive workshops (including virtual formats) to educate stakeholders and build internal capability.
Ongoing engineering support including design reviews, analysis of security testing results, responses to regulatory questions, and support for healthcare organization questionnaires.
Lead and perform cybersecurity activities for regulatory submissions, including architecture/data flow diagrams, threat modeling, requirements documentation, V&V support, labeling inputs, and submission guidance.
Comprehensive evaluations of organizational product security processes and technical controls, including benchmarking against regulatory and standards documents and identification of remediation actions.
Develop processes, work instructions, and templates to integrate cybersecurity into existing quality management systems and update related procedures (design control, risk management, complaint handling).
Deliver threat-modeling training and facilitate interactive workshops (including virtual formats) to educate stakeholders and build internal capability.
Expertise Areas
- Medical device cybersecurity
- Regulatory submission support (FDA and international)
- Product security engineering
- Quality Management System integration for cybersecurity
Key Technologies
- Threat modeling
- Architecture and data flow diagramming
- Static application security testing (SAST)
- Software composition analysis (SCA)
News & Updates
Our Managing Director, Colin Morgan, recently participated on a panel discussion entitled Managing Cyber Risk for Life Sciences Technology. The discussion focused on managing cybersecurity risks in the rapidly converging life sciences and technology industries, especially in the context of COVID-19.
Regulatory guidance from Health Canada and the Australian TGA on pre-market and lifecycle cybersecurity requirements for medical devices, emphasizing the importance of integrating cybersecurity into quality management systems.
Apraciti submitted comments to the FDA on their draft guidance for managing cybersecurity in medical devices, supporting efforts to improve safety and security.
A comprehensive list of regulatory publications from various countries and agencies related to medical device cybersecurity, including guidance from the FDA, Health Canada, TGA, and others.
Our Managing Director, Colin Morgan, recently participated on a panel discussion entitled Managing Cyber Risk for Life Sciences Technology. The discussion focused on managing cybersecurity risks in the rapidly converging life sciences and technology industries, especially in the context of COVID-19.
Regulatory guidance from Health Canada and the Australian TGA on pre-market and lifecycle cybersecurity requirements for medical devices, emphasizing the importance of integrating cybersecurity into quality management systems.
Apraciti submitted comments to the FDA on their draft guidance for managing cybersecurity in medical devices, supporting efforts to improve safety and security.
A comprehensive list of regulatory publications from various countries and agencies related to medical device cybersecurity, including guidance from the FDA, Health Canada, TGA, and others.