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.
Expertise
Expertise
Whether you are a start-up that wants to turn a new concept idea into reality or an established organization looking for support, we support you at any stage to create high-performance medical devices that meet the real needs of your market and users.
Commercial, Market Access
Our 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 mature products. Our focus is integrated products and beyond-the-pill solutions, precision and personalized medicine, innovative diagnostics, and digital health/therapeutics. Read More
Disease areas: Neuroscience, Mental Health, Cardiometabolic, Diabetes, Women’s Health, Oncology, Infectious Diseases, Rare Diseases.
Software 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
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
Commercial, Market Strategy
Our 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 mature products. Our focus is integrated products and beyond-the-pill solutions, precision and personalized medicine, innovative diagnostics, and digital health/therapeutics. Read More
Disease areas: Neuroscience, Mental Health, Cardiometabolic, Diabetes, Women’s Health, Oncology, Infectious Diseases, Rare Diseases.
Software 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
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
By combining strategy, design, and engineering talents, we offer an integrated ISO 13485-certified approach to medical device development and high-tech product development. Since 2022, we have worked together to develop the best solution from the earliest stages of a product definition to production.
Human approach
We’re led by the insights we uncover through our human-centric approach to discovery for every product.
Understanding problem
Patients must be empowered in their daily lives. Being decision-makers in their treatment is essential.
User-friendly design
We invest time understanding the project’s needs, ensuring our products feature top design and usability.
Human approach
We’re led by the insights we uncover through our human-centric approach to discovery for every product.
Understanding problem
Patients must be empowered in their daily lives. Being decision-makers in their treatment is essential.
User-friendly design
We invest time understanding the project’s needs, ensuring our products feature top design and usability.
Product lifecycle
Product lifecycle
We support both high-potential start-ups that need resources to bring new technologies to life and established organizations looking for new sources of digital health product innovation and global market growth.
Product Concept
We work closely with partners, keeping their business objectives and end users at the forefront. By gathering patient and user feedback, we identify opportunities for improvement that inform our user research and validation efforts. Our skilled team adopts a human-centered design approach, ensuring a balance between an outstanding user experience and regulatory compliance.
Design, Development
Regulatory expertise is essential to ensure each product meets the relevant requirements. Our agile teams, specializing in native mobile, desktop, and web applications, develop SaMD and DTx solutions with quality as their top priority. We maintain an ISO 13485:2016-accredited QMS that supports the design, development, launch, and maintenance of our software products.
Go-To-Market, Validation
Our go-to-market and validation services for medical devices ensure compliance with complex legal and regulatory requirements across different markets. We also help with user acquisition, navigating regulatory constraints, and identifying effective channels for product promotion.
Post-Market, Maintenance
After a medical device is released, we continuously monitor its performance to ensure ongoing safety, effectiveness, and compliance. We investigate any adverse events, address them promptly, and provide updates or new versions if necessary. Our GDPR- and HIPAA-compliant cloud infrastructure supports secure data management and regulatory compliance. When a device reaches the end of its lifecycle, we remove it from regulatory listings and decommission data and applications, ensuring a smooth and secure process for our clients.
Product Concept
We work closely with partners, keeping their business objectives and end users at the forefront. By gathering patient and user feedback, we identify opportunities for improvement that inform our user research and validation efforts. Our skilled team adopts a human-centered design approach, ensuring a balance between an outstanding user experience and regulatory compliance.
Design, Development
Regulatory expertise is essential to ensure each product meets the relevant requirements. Our agile teams, specializing in native mobile, desktop, and web applications, develop SaMD and DTx solutions with quality as their top priority. We maintain an ISO 13485:2016-accredited QMS that supports the design, development, launch, and maintenance of our software products.
Go-To-Market, Validation
Our go-to-market and validation services for medical devices ensure compliance with complex legal and regulatory requirements across different markets. We also help with user acquisition, navigating regulatory constraints, and identifying effective channels for product promotion.
Post-Market, Maintenance
After a medical device is released, we continuously monitor its performance to ensure ongoing safety, effectiveness, and compliance. We investigate any adverse events, address them promptly, and provide updates or new versions if necessary. Our GDPR- and HIPAA-compliant Microsoft Azure cloud infrastructure supports secure data management and regulatory compliance. When a device reaches the end of its lifecycle, we remove it from regulatory listings and decommission data and applications, ensuring a smooth and secure process for our clients.
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.