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FDA issues draft guidance on AI-enabled medical device software functions
A closer look at the FDA’s draft guidance on AI-driven drug data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