Services
Services
We support clinical teams across condition areas through custom digital health solutions.
We support clinical teams across condition areas through custom digital health solutions.
Expertise in digital healthcare
Expertise in digital healthcare
Health Economics, Outcomes Research
Our support includes strategic HEOR planning, systematic reviews, validated clinical outcome assessments, de novo and adapted economic models, and patient preference studies. We also provide formal and informal scientific advice, briefings, and value communications to effectively convey product benefits and facilitate reimbursement.
Commercial, Market Access
Aura Health experts have 15+ years of experience working on life science market access and commercialization strategies at the global level. We act as a trusted partner to pharmaceutical and medical device clients, scoping, designing, and executing projects that inform complex strategic decisions for launching and maturing products.
Quality Assurance
Our quality assurance 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.
AI, Product 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 Research
We guide medical device manufacturers through all the steps needed for clinical research, making the journey from early device development and working with regulators, through to study design, enrollment, and effective clinical trial execution.
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.