Dipl.Ing. Marvie Demit

I joined RobotDreams GmbH first as Investor, then as Interim Chief Product Officer to support the entire Team to develop an AI as Medical Device for FDA/IVDR. My main activities are offering advice for their Product Roadmap, advising in establishing the AI and SW Development Lifecycle as well as strategic advice in reimbursement and integration of the AI Medical Devices to healthcare systems

I founded ArnoldAI right after VividSolutions, building a patentable LLM Application Layer to provide an ISO compliant Agent Builder towards regulated Industries

As a Partner at Quaregia, I lead AI-driven product improvements, DevOps and cross-functional delivery, regulatory compliance, stakeholder collaboration, cybersecurity, machine learning for diagnostics, and rigorous documentation and validation to meet quality and strategic goals.

I support Exploris Health in successfully CE-marking their AI medical device by leading technical product ownership and Agile delivery, guiding architecture and the full software lifecycle, owning verification/validation, configuration/change management, risk and usability engineering, and cybersecurity strategy, while collaborating across teams to define priorities and drive continuous improvement.

As an Agile PM consultant for Exscientia, I defined product strategy, built a Confluence QMS and Jira ALM, stood up an Agile PMO and project framework, trained teams, drove continuous improvement, aligned cross-functional stakeholders, reported to leadership, and delivered compliant, effective AI SaMD projects.

I founded VividSolutions, a B2B digital-health consultancy that pairs regulatory and UX expertise with hands-on development and modernization of regulated health software and devices.

I led design thinking and sprints to prototype MVPs, partnered with business/product/engineering to define innovative multi-platform experiences, launched a minimum viable design system (fonts, icons, palette) and Storybook transition, delivered the GSPR Assistant Tool strategy/roadmap, and drove QA across the release plan.

I drove operational excellence by enforcing SOPs, leading and scaling Operations, setting OKRs and KPIs, partnering with executives on strategy and budgets, optimizing processes and vendor relationships, serving as SME for regulatory-tech initiatives, and delivering key wins including an AI/MD product lifecycle with full traceability, a Confluence/Jira eQMS transition, and the launch of an IVD bioinformatics pipeline.

I led research and tech scouting for AI-based genetic testing, owned end-to-end requirements and usability work, translated business needs into workflows and prototypes across interfaces, and delivered key outcomes including a minimum viable genomics database and SOPs for data curation, integration, software development, QA, sales, and human factors.

I partnered across the organization to leverage data for CGM solutions, analyzed patient data and visualization usability, evaluated external predictive tools, built A/B testing and model quality frameworks, established performance monitoring methods, and delivered key assets including SOPs, conceptual designs, work instructions for CGM reporting, and an assessment of Neura AI integration.

I led DACH product approvals and accreditations, validated product–market fit and key assumptions, supported GAIA’s Urerde certification, and secured ECO certification for the main product.

I planned laboratory and sample receipt schedules, monitored and validated analytical processes and devices, organized device acceptance and reference material tests, and delivered workflow improvements across hematology, chemistry, immunology, and sample receipt/archival.

I prepared and tested samples, maintained records, analyzed and documented results, supported research prep, ensured lab cleanliness and sterilization, handled admin tasks, and gained hands-on experience in PCR and immunohistochemistry.

Coming Soon!

I have delivered a targeted EU AI Act workshop for the WKO Austrian Economic Chamber, tailored to SMEs—focusing on developer obligations (risk classification, technical documentation, data governance, human oversight) and practical guidance for consultants integrating AI into services, with checklists and templates to operationalize compliance.

I reviewed Sanofi's Software File for a Mobile Health App, ensuring compliance with regulatory standards and recommending enhancements for quality, user experience, and regulatory adherence under IEC 62304, IEC 62366 and ISO 14971.

I reviewed Intex GmbH's Usability Engineering File for their Pregnancy Test Application, ensuring compliance with regulations and providing recommendations to enhance usability and user experience under IEC 62366 and Human Factors Guidelines by the FDA through QUAREGIA's partnership referral.

I conducted a cybersecurity workshop for Deepeye Medical to enhance the security of their application in line with state-of-the-art cybersecurity standards for medical devices. The workshop focused on training the team in cybersecurity best practices, vulnerability identification, and implementing robust security measures to protect sensitive medical data through QUAREGIA's partnership referral.

I founded VividSolutions, a B2B digital-health consultancy that pairs regulatory and UX expertise with hands-on development and modernization of regulated health software and devices.

I led design thinking and sprints to prototype MVPs, partnered with business/product/engineering to define innovative multi-platform experiences, launched a minimum viable design system (fonts, icons, palette) and Storybook transition, delivered the GSPR Assistant Tool strategy/roadmap, and drove QA across the release plan.

I drove operational excellence by enforcing SOPs, leading and scaling Operations, setting OKRs and KPIs, partnering with executives on strategy and budgets, optimizing processes and vendor relationships, serving as SME for regulatory-tech initiatives, and delivering key wins including an AI/MD product lifecycle with full traceability, a Confluence/Jira eQMS transition, and the launch of an IVD bioinformatics pipeline.

I led research and tech scouting for AI-based genetic testing, owned end-to-end requirements and usability work, translated business needs into workflows and prototypes across interfaces, and delivered key outcomes including a minimum viable genomics database and SOPs for data curation, integration, software development, QA, sales, and human factors.

I partnered across the organization to leverage data for CGM solutions, analyzed patient data and visualization usability, evaluated external predictive tools, built A/B testing and model quality frameworks, established performance monitoring methods, and delivered key assets including SOPs, conceptual designs, work instructions for CGM reporting, and an assessment of Neura AI integration.

I led DACH product approvals and accreditations, validated product–market fit and key assumptions, supported GAIA’s Urerde certification, and secured ECO certification for the main product.

I planned laboratory and sample receipt schedules, monitored and validated analytical processes and devices, organized device acceptance and reference material tests, and delivered workflow improvements across hematology, chemistry, immunology, and sample receipt/archival.

I prepared and tested samples, maintained records, analyzed and documented results, supported research prep, ensured lab cleanliness and sterilization, handled admin tasks, and gained hands-on experience in PCR and immunohistochemistry.