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Strategy and consulting in life sciences

Strategy and consulting in life sciences

Discover more about our capabilities

Discover our capabilities

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/subcontractor 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/subcontractor to develop products for a global market.

EUDAMED device applications are generally automatically registered unless the Basic UDI-DI information needs to be verified by the Notified Body.
Medical device design & regulation

ISO 13485 certification

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.

Experts in digital health

Since 2022, our teams have worked together to develop the best solutions in biotech, medtech, and life sciences, from the earliest stages to production.

User-friendly design

We invest time in understanding the client project’s needs, ensuring our digital health products feature top design and usability.

Understanding problem

Patients must be empowered in their daily lives. Being decision-makers in their treatment is essential, as it gives them greater control over their care.

Human approach

By integrating research, empathy, and innovation, we create digital health products that are not only functional but also intuitive, accessible, and impactful.

Safety comes first

Driven by medical device eQMS, cybersecurity, and quality processes. Our approach prioritizes patient safety at every stage, from development to implementation.

ISO 13485 certification

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.

Experts in digital health

Since 2022, our teams have worked together to develop the best digital health solutions in biotech, medtech, and life sciences, from the earliest stages to production.

User-friendly design

We invest time in understanding the client project’s needs, ensuring our digital health products feature top design and usability.

Understanding problem

Patients must be empowered in their daily lives. Being decision-makers in their treatment is essential, as it gives them greater control over their care.

Human approach

By integrating research, empathy, and innovation, we create digital health products that are not only functional but also intuitive, accessible, and impactful.

Safety comes first

Driven by medical device eQMS, cybersecurity, and quality processes. Our approach prioritizes patient safety at every stage, from development to implementation.

In today’s technology-driven world, the healthcare industry is continuously adopting digital solutions to enhance patient care and optimize operational efficiency.
Medical device design & regulation

Professionals with clinical expertise

Professionals with clinical expertise

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.

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 

Disease areas: Neuroscience, Mental Health, Cardiometabolic, Diabetes, Women’s Health, Oncology, Infectious Diseases, Rare Diseases.

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 

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

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

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.

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 

Disease areas: Neuroscience, Mental Health, Cardiometabolic, Diabetes, Women’s Health, Oncology, Infectious Diseases, Rare Diseases.

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 

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

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

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.

Medical Device Stratey & Consulting
Medical Device Stratey & Consulting

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

Understand the problem and the market

Define

Define the digital health product

Elaborate

Develop a digital health product

Adapt

Test and certify digital health product

Launch

Bring digital health product to the market

Understand the problem and the market

Define the digital health product

Develop a digital health product

Test and certify digital health product

Bring digital health product to the market

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.

Ready to transform chronic care?

Ready to transform chronic care?