Healthtech & Medtech
Connected medical devices, AI-driven diagnostics, and digital therapeutics are transforming healthcare but innovation must be matched by rigorous compliance with medical device regulations, data protection requirements, and cybersecurity standards.
Digital health innovations from connected medical devices and wearable health monitors to AI-powered diagnostic tools and digital therapeutic applications are fundamentally transforming patient care, clinical research, and data-driven medicine. Yet these innovations introduce heightened regulatory and data protection requirements that organisations must navigate carefully. In a complex landscape governed by EU MDR, IVDR, FDA regulations, and global privacy laws, ensuring comprehensive compliance throughout the product lifecycle is essential.
HealthTech Compliance Requirements
Connected medical devices, AI-driven diagnostics, and digital therapeutics are transforming healthcare but innovation must be matched by rigorous compliance with medical device regulations, data protection requirements, and cybersecurity standards.
Medical devices processing personal data must comply with both MDR/IVDR requirements and data protection regulations. This includes addressing data protection in technical documentation, clinical evaluation reports, and risk management files. The intersection of device regulation and privacy creates unique compliance challenges requiring specialized expertise.
In Vitro Diagnostics present particular data protection challenges especially genetic testing and companion diagnostics processing highly sensitive information. IVDR compliance requires attention to data management, traceability, and validation processes while maintaining rigorous privacy protections throughout the diagnostic workflow.
Health and medical apps must navigate complex regulatory classification questions while addressing privacy requirements spanning multiple jurisdictions. This includes determining whether apps qualify as medical devices, implementing appropriate privacy controls, and ensuring secure data handling across platforms and geographies.
Privacy by design must be embedded throughout device development from initial concept through design, manufacturing, and post-market activities. This includes mapping data flows, defining lawful bases, implementing appropriate consent mechanisms, and ensuring compliant vendor relationships.
Market authorisation submissions must address data protection comprehensively including privacy impact assessments, data handling documentation, and cybersecurity measures. Regulators increasingly scrutinise data protection practices during device reviews.
Post-market surveillance activities generate and process personal data requiring privacy compliance attention. Incident reporting, vigilance activities, and ongoing performance monitoring must be conducted within appropriate privacy frameworks.
How iliomad Health Data Can Help You
iliomad Health Data helps MedTech, HealthTech ,and Digital Health companies design, build, and deploy solutions that are not only innovative and clinically valuable but also fully compliant, rigorously secure, and commercially scalable across all jurisdictions. Our consultants bring deep, hands-on experience in MDR, IVDR, and global MedTech regulatory frameworks, ensuring your technology complies from pre-market design through post-market surveillance.
FAQs
Our frequently questions
Connected medical devices, AI-driven diagnostics, wearable health monitors, and digital therapeutics must simultaneously comply with medical device regulations (EU MDR/IVDR, FDA), data protection requirements (GDPR, HIPAA), cybersecurity standards (ISO 27001, IEC 62443, FDA cybersecurity guidance), and for AI-enabled devices, the EU AI Act—creating a complex regulatory landscape where innovation and compliance must advance together. With experience across 66 countries, we provide integrated medical device regulation compliance, data protection (privacy by design, patient data management), AI compliance (algorithm validation, conformity assessment), and cybersecurity (device security, post-market surveillance) services throughout the entire product lifecycle from concept through post-market surveillance.
The highest-impact challenges include MDR/IVDR technical documentation gaps that delay notified body approval, inadequate cybersecurity controls in connected devices exposing patient data and device functionality to threats, AI algorithms in diagnostic or therapeutic devices lacking EU AI Act conformity assessment and transparency documentation, privacy by design failures where data protection isn't integrated from product conception, insufficient post-market surveillance systems failing to detect safety issues or data breaches, and non-compliant cross-border patient data flows for cloud-connected devices. These issues trigger regulatory rejections, market access delays, authority investigations, product recalls, and reputational damage that can be fatal for emerging MedTech companies.
We provide data protection compliance (privacy by design, patient data management, GDPR for connected devices), AI regulatory compliance (EU AI Act conformity assessment, algorithm classification, technical documentation for AI-enabled medical devices), and cybersecurity regulatory compliance (MDR/IVDR cybersecurity requirements, ISO 27001/IEC 62443 alignment, post-market surveillance, incident response). With experience across 66 countries, we harmonize data protection, AI governance, and cybersecurity obligations throughout your product lifecycle—ensuring regulatory compliance without duplicative processes.
Contact us through our website form or email directly. We'll schedule an initial consultation to understand your regulatory landscape, identify immediate priorities, and propose a tailored engagement that fits your timeline and budget.
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