Solutions for AI and medical device companies
Solutions for AI and medical device companies
We support clinical teams across condition areas through custom AI and medical device solutions.
We support clinical teams across condition areas through custom AI and medical device solutions.
Supporting your device through the whole lifecycle
Supporting your device through the whole lifecycle
Health Economics
We provide health economic modeling and outcomes research for digital health and medical devices. We conduct early economic modeling, budget impact, and cost-effectiveness analyses as well as uncertainty assessments to deliver robust evidence for payers, regulators, and stakeholders. Our work supports the transition of innovation from concept to adoption by proving clinical benefit, cost savings, and long-term sustainability.
Market Access
Aura Health helps you align your solutions with clinical and market needs, create clear value propositions, map stakeholders and payers, and design go-to-market plans that include pricing, reimbursement, launch execution, and competitive positioning. With the right strategy, your medical and digital health innovations become viable, adopted, and trusted in global markets.
Intellectual Property
Our team provides end-to-end IP support. We help identify and secure patents, software, algorithms, and designs, develop robust IP strategies, and conduct Freedom to Operate analyses to reduce legal and market risks. Our team guides you through patent filing and international protection while ensuring continuous monitoring and portfolio management. With the right IP framework, your solutions gain security, credibility, and stronger market value.
Quality Assurance
Our QA team can support your team in becoming familiar with the medical standards and the regulatory process. Our role is to analyze the standards and regulations to establish the design requirements according to the identified specifications.
Software, AI Medical Device Development
Writing code is just one of many things our software engineers excel in. They work closely with our designers and embedded software engineers to choose the perfect technology stack. They also collaborate hand in hand with our quality assurance team for your project needs in compliance with safety standards.
Regulatory Compliance
Our teams develop your products according to applicable standards to meet the medical device’s regulatory requirements. Our process speeds up the time to market and facilitates product approval by the relevant authorities.
Clinical Evaluation
We provide end-to-end clinical evaluation services for all software-based medical devices, including health apps, SaMD, and AI-driven technologies. Our purpose is to help you prove safety, performance, and clinical benefit, before and after market entry.
Standards and certifications
Standards and certifications
ISO 13485:2016
Quality Management for Medical Devices
ISO 14971
Application of Risk Management to Medical Devices
The standard outlines the procedures for identifying medical device hazards, assessing and evaluating associated risks, implementing controls, and continuously monitoring their effectiveness.
IEC 62304
Medical Device Software Lifecycle Processes
IEC 82304
Health Software Product Safety
UL-2900-2-1
Software Cybersecurity
IEC 62366
Medical Device Usability
GAMP 5
A risk-based approach to compliant GxP Computerized system
ISO 20916:2019
In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
ISO 14155:2020
Clinical investigation of medical devices for human subjects — Good clinical practice
This international standard addresses good clinical practices for the design, conduct, recording, and reporting of clinical investigations carried out on human subjects to assess the safety and performance of medical devices for regulatory purposes.
HIPAA
Health Insurance Portability and Accountability Act
<p>The Health Insurance Portability and Accountability Act (HIPAA) of 1996 establishes federal standards protecting sensitive health information from disclosure without a patient’s consent.</p>
GDPR
General Data Protection Regulation (EU) 2016/679
A legal framework in the European Union that regulates data protection and privacy for individuals within the EU and EEA, while also overseeing the transfer of personal data outside these regions.