Protecting compliance and value with continuous monitoring and updates.
Our team builds beyond-the-pill solutions that can be used instead of conventional drug therapies, offering entirely new and alternative approaches for all chronic disease patients. We can act as a Critical Supplier or Legal Manufacturer to develop products for a global market.
Our team builds beyond-the-pill solutions that can be used instead of conventional drug therapies, offering entirely new and alternative approaches for all chronic disease patients. We can act as a Critical Supplier or Legal Manufacturer to develop products for a global market.
Digital Companions
From initial concept and user research to global launch and ongoing optimization, our end-to-end services ensure your therapy stands out in crowded markets and delivers measurable impact at every stage.
Chronic Disease Management
We guide our clients through every stage, from initial concept and the development of regulated software as a medical device (SaMD) to product launch and ongoing operations—often serving as the legal manufacturer.
Digital Therapeutics (DTx)
We act as a full-lifecycle partner, handling development, management, and operation of DTx solutions. We can take on legal manufacturer responsibilities while allowing pharma companies to maintain commercial ownership of their products.
Wearables and Implantables
Integrating disease management solutions with wearable, implantable, and personal medical devices to maximize therapeutic and operational value, advancing patient and provider experience, optimizing therapy adherence, and enabling improved clinical outcomes and quality of life.
ISO 13485 Certified Partner
Certified by a BSI-accredited Notified Body, we combine strategy, design, and engineering talents with an integrated ISO 13485 approach to medical device and high-tech product development.
Critical Supplier or Legal Manufacturer
Through collaboration with our partners, we act as a Critical Supplier or Legal Manufacturer.
Evidence-Based Strategy
Partnering from discovery to post-market optimization, we align stakeholder goals, validate clinical and economic value, and operationalize SaMD or DTx solutions that scale across geographies without disrupting care delivery.
Safety Comes First
Driven by medical device eQMS, cybersecurity, and quality processes. Our approach prioritizes patient safety at every stage, from development to implementation.
Human-Centered Approach
By integrating research, empathy, and innovation, we create digital health products that are not only functional but also intuitive, accessible, and impactful.
Digital Companions
From initial concept and user research to global launch and ongoing optimization, our end-to-end services ensure your therapy stands out in crowded markets and delivers measurable impact at every stage.
Chronic Disease Management
We guide our clients through every stage—from initial concept and the development of regulated software as a medical device (SaMD) to product launch and ongoing operations—often serving as the legal manufacturer.
Digital Therapeutics (DTx)
We act as a full-lifecycle partner, handling development, management, and operation of DTx solutions. We can take on legal manufacturer responsibilities while allowing pharma companies to maintain commercial ownership of their products.
Wearables and Implantables
Integrating disease management solutions with wearable, implantable, and personal medical devices to maximize therapeutic and operational value, advancing patient and provider experience, optimizing therapy adherence, and enabling improved clinical outcomes and quality of life.
ISO 13485 Certified Partner
Certified by a BSI-accredited Notified Body, we combine strategy, design, and engineering talents with an integrated ISO 13485 approach to medical device and high-tech product development.
Critical Supplier or Legal Manufacturer
Through collaboration with our partners, we act as a Critical Supplier or Legal Manufacturer.
Evidence-Based Strategy
Partnering from discovery to post-market optimization, we align stakeholder goals, validate clinical and economic value, and operationalize SaMD or DTx solutions that scale across geographies without disrupting care delivery.
Safety Comes First
Driven by medical device eQMS, cybersecurity, and quality processes. Our approach prioritizes patient safety at every stage, from development to implementation.
Human-Centered Approach
By integrating research, empathy, and innovation, we create digital health products that are not only functional but also intuitive, accessible, and impactful.
Guiding companies through the medical device lifecycle
Guiding companies through the medical device lifecycle
Whether you are a start-up wanting to turn a new concept idea into reality or an established organization looking for support, we support you at any stage to create digital health products that meet your market’s and users’ needs.
Whether you are a start-up wanting to turn a new concept idea into reality or an established organization looking for support, we support you at any stage to create digital health products that meet your market’s and users’ needs.
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. Read More
Commercial, Market Strategy
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 in scoping, designing, and executing projects that inform complex strategic decisions for launching and maturing products. Read More
Health Economics, Outcomes Research
We use proven methods to help pharmaceutical, biotech, and medical device clients generate Health Economics and Outcomes Research (HEOR) evidence, address HTA requirements, and market access. 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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
Commercial, Market Strategy
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 in scoping, designing, and executing projects that inform complex strategic decisions for launching and maturing products. Read More
Health Economics, Outcomes Research
We use proven methods to help pharmaceutical, biotech, and medical device clients generate Health Economics and Outcomes Research (HEOR) evidence, address HTA requirements, and secure market access. 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. Read More
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. Read More
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. Read More
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. Read More
By applying the same process to design and develop a new product, we ease the emergence of new ideas, thinking, and communication.
By applying the same process to design and develop a new product, we ease the emergence of new ideas, thinking, and communication.
Discover
Analyzing where clinical pain points meet commercial upside.
Define
Locking in requirements that satisfy both patients and regulators.
Elaborate
Building, testing, and refining the device in fast, documented cycles.
Adapt
Proving safety and performance, securing CE or FDA approval.
Launch
Turning clearance into adoption through data-driven market entry.
Maintain
Protecting compliance and value with continuous monitoring and updates.
Discover
Analyzing where clinical pain points meet commercial upside.
Define
Locking in requirements that satisfy both patients and regulators.
Elaborate
Building, testing, and refining the device in fast, documented cycles.
Adapt
Proving safety and performance, securing CE or FDA approval.
Launch
Turning clearance into adoption through data-driven market entry.
Maintain
Our expertise ensures compliance with ISO 13485:2016 standard
This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry.
Our expertise ensures compliance with ISO 13485:2016 standard
This internationally agreed standard sets out the requirements for a quality management system specific to the medical device industry.
Latest news
Latest news
Stay informed with the latest insights and updates from Aura Health.
Stay informed with the latest insights and updates from Aura Health.
