Insights for SaMD and AI
medical devices
Practical guides and analysis from our regulatory, clinical and engineering team, written for teams building regulated medical software.
All articles
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Choosing a Notified Body for Software as a Medical Device
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How to structure a SaMD software architecture for FDA pre-submission
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Is your app a mental health SaMD or a wellness product?
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How to use LLMs in SaMD regulatory documentation without losing control
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EUDAMED registration is now mandatory if you’re looking to bring a medical device to market
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Why does securing a CPT code for a medical device need to start before your pivotal study?
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What the EU MDR 2026 amendments mean for your SaMD product strategy
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Insights from NHS at Health Innovation Talks Zagreb
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Clinical data requirements for medical device CE marking
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UDI registration and device traceability in EUDAMED
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Schizophrenia evidence-based innovations for early detection and personalized therapy
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Integrating IEC 62366-1 usability engineering into medical device development
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Research driven medical device innovation combining real world insights and theoretical research
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Why partnering with a specialized developer delivers SaMD-grade digital platforms faster
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Aura Health at Morning Health Talks 2025 in Zagreb, Croatia
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How a MedTech data strategy transforms medical devices into patient outcomes
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Pharma’s digital health solutions can’t be one-size-fits-all
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A detailed regulatory guide for transferring your Swiss Authorized Representative (CH-REP)
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China opens its first AI hospital that can diagnose 10,000 patients in days.
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The lifecycle of healthcare AI, from concept to clinical implementation
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New aging research and drug discovery strategies in 2025
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How does behavior change design motivate patients to continue medication?
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A personal mission for sustainable growth in the MedTech industry
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CE certification for medical devices and IVDRs – step-by-step guide
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FDA issues draft guidance on AI-enabled medical device software functions
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A closer look at the FDA’s draft guidance on AI-driven drug data
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Aura Health guides you on how to prepare for ISO 13485 certification
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Our CTO Aaron speaks about innovative MedTech which combines digital health and medical devices
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Guide to ISO 14155 standard in medical device manufacturing
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EU MDR roadmap – a guide to achieving medical device compliance
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Join us at the first HealthTech Adria Conference 2024 in Split, Croatia
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Basic guide for implementing patient-centered design into Software as Medical Device
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Improving patient engagement by integrating medical devices data
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Introduction to Regulatory Affairs in Clinical Research
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European Medical Device Database
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Contract manufacturing for medical devices in Europe
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How to register medical devices and IVDs in EUDAMED
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What are patient digital twins?
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How to develop your digital health app design strategy?
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The top 5 obstacles SaMD innovators face while creating medical software
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ISO 14791 Quality Management System Guidelines for SaMD Risk Management
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Waterfall or Agile in Medical Device Development (SaMD)?
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How does Age Tech support elderly people?
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What are the five phases of SaMD medical device software development?
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Building regulated medical digital products in the European Union