CyberActa
James Isaacson has a wealth of experience in various roles within the medical device industry, with a focus on Quality Systems, Design Assurance, and Project Management. With a background in Engineering from top universities, James has held leadership positions at well-known companies such as JUUL Labs, Fresenius Medical Care, and GE Healthcare. James is currently serving as the Vice President of Quality and Engineering at Alucent Biomedical, Inc., while also working as a Product Development Expert at CyberActa and a Medical Device Consultant as an Independent Consultant. James' expertise lies in creating and implementing Quality Systems elements, project management, and ensuring compliance with regulatory requirements.
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CyberActa
CyberActa is a boutique consultancy empowering companies in their cybersecurity, privacy, data integrity, regulatory compliance, and commercialization endeavors. We assist on matters spanning the product life cycle, from product development and clinical trials, through the FDA, EMA, PMDA, and TGA premarket review processes, to post-market compliance, GxP practices, software validation, and Quality System requirements. Whether traditional medicinal products and devices, rapidly evolving medical and health technology products, such as a SaMD or digital diagnostic tools, we have extensive knowledge of the governing laws and regulations and broad-based practical experience with their application in advising clients to achieve competitive advantage by guiding on significant events that could adversely affect product quality, submission approval, compliance status, or pose a significant business risk. Our services cover: - Medical Device Cybersecurity Management - end-to-end consulting and creation of submission package (510(k), PMA) and addressing any Additional Information (AI) requests pertaining to the filing itself. - Medical Device Cybersecurity Threat Modeling, SBOM analysis and generation, Vulnerability Assessment and Penetration Testing, Continuous Threat Monitoring, Supply Chain Risk Management (SCRM), and Cybersecurity Engineering. - SaMD, SiMD development, regulatory guidance, and filing, - Privacy & Data Governance (HIPAA, GDPR, CCPA) - Computer System Validation - GxP Data Integrity - GxP Regulatory Intelligence & Compliance - vCISO Security Consulting - On-going evaluation of existing corporate security posture, IT architecture, investment strategies, and compliance documentation. Cyber Security roadmap, medical device architecture, and addresses advanced Cyber Security Challenges such as insider threats, Cyber SCRM, and fraud detection. This service covers both corporate and individual devices/systems.