Brett Marshall Email & Phone Number

With over 25 years of consulting experience across Medical Devices, Health IT, Information and Cyber Security, Governance, Risk Management, and Compliance, I specialize in helping clients navigate complex regulatory landscapes and integrate innovative technologies to enhance systems, ensure safety and compliance, and improve outcomes. My expertise spans the entire lifecycle of technology solutions, from strategic planning and design to implementation and regulatory compliance.I have extensive experience in medical devices, including Software as a Medical Device (SaMD), supporting compliance with global regulatory frameworks such as EU MDR, UK MDR, US FDA (including 510(k) submissions), Brazil ANVISA, and MDSAP. My work includes implementing ISO 13485 Quality Management Systems (QMS), applying ISO 14971 for medical device risk management, and achieving ISO 27001 certification for information security. Additionally, I have expertise in developing AI Management Systems aligned with ISO 42001 (forthcoming).I am also starting to help clients integrate AI technologies into healthcare solutions while ensuring alignment with the EU AI Act and other emerging AI regulations and standards.I thrive on getting into the detail, producing comprehensive compliance documentation required to meet regulatory standards, and representing clients at external audits to secure certifications or accreditations. As a cybersecurity expert, I have successfully led initiatives to achieve ISO 27001 certification, implemented advanced cybersecurity frameworks (including NIST, STRIDE, and DREAD), and provided advisory services to medical device manufacturers to address unique security challenges.My career includes leadership roles such as Chief Information Security Officer (CISO) and founding consultancy firms focused on transforming businesses through technology and compliance. I excel in aligning technology solutions with business, product, and service objectives, managing large-scale programs, leading small agile-focused teams, and everything in between. My ability to address the challenges of highly regulated environments ensures clients meet stringent standards while driving innovation and maintaining a competitive advantage.

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  Founder

  Neural Vibe

  May 2024 - Present - London Area, United Kingdom

  Founder of Neural Vibe, a growing consultancy that helps our clients identify and implement AI technologies that offer them the greatest opportunities, seamlessly integrated into their business operations, services offerings and product lines. Our approach ensures strict compliance with regulatory requirements, underpinned by the OECD AI principles, aligning with industry best practices and appropriate international standards. Helping clients transform into an AI-Enhanced business. At Neural Vibe you can feel the AGI.