Our team code to save patients lives
Our team code to save patients lives
Experts in digital health, we develop regulated solutions motivated by our desire to make a difference in people’s lives. With headquarters in Croatia and a global focus, our teams of professionals provide the market with top-notch products in life sciences.
A team of in-house professionals
A team of in-house professionals
Medical Affairs
Regulatory Affairs
An accredited RA partner providing consulting services for the complete lifecycle of medical devices. We deliver expert guidance from the initial design phase to the final stages of commercialization, ensuring compliance with all relevant regulations.
Quality Assurance
Partners rely on us to fulfill QA requirements. We have extensive expertise working with regulators and Notified Bodies to help you manage the processes for medical device product evaluation, approval, and regulatory compliance.
Strategy
Getting professional advice when developing medical device software will help you maintain industry best practices and regulatory compliance. By placing a high priority on quality, we guarantee dependable and safe software operation, which benefits both patients and healthcare professionals.
Design
We make sure that our products satisfy the demands of patients and medical professionals by conducting thorough user research, iterative prototyping, and usability testing. This strategy improves usability, accessibility, and user satisfaction, which boosts adoption and improves health results.
Development
We provide digital health Software as a Medical Device (SaMD) and Digital Therapeutics (DTx) software solutions that exceed performance, safety, and functionality standards in the life science sector by utilizing advanced AI algorithms and rigorous testing methodologies.
Driving change in digital health
Driving change in digital health
Our highly skilled medical software developers work across every modern framework and language. Our extensive healthcare experience equips engineers to anticipate technology risks and help clients build optimized applications.
Our highly skilled medical software developers work across every modern framework and language. Our extensive healthcare experience equips engineers to anticipate technology risks and help clients build optimized applications.
Quality Assurance, Testing
Our life science partners trust us to meet or exceed the QA standards of EMA, FDA, MHRA, and other regulatory agencies. You can navigate the procedures for medical device product review, approval, and regulatory compliance with the support of our experience working with regulators and Notified Bodies. Read More
Quality Assurance, Testing
Our life science partners trust us to meet or exceed the QA standards of EMA, FDA, MHRA, and other regulatory agencies. You can navigate the procedures for medical device product review, approval, and regulatory compliance with the support of our experience working with regulators and Notified Bodies. Read More
Regulatory, Medical Affairs
An accredited medical and regulatory affairs partner providing consulting services for the complete lifecycle of medical devices and in vitro diagnostics (IVDs). We deliver expert guidance from the initial design phase to the final stages of commercialization, publication planning, and ensuring compliance with all relevant regulations. Read More
Regulatory, Medical Affairs
An accredited medical and regulatory affairs partner providing consulting services for the complete lifecycle of medical devices and in vitro diagnostics (IVDs). We deliver expert guidance from the initial design phase to the final stages of commercialization, publication planning, and ensuring compliance with all relevant regulations. Read More
SaMD, Digital Therapeutics
Medical disorders are treated, managed, and prevented with specialized therapy modalities. To deliver evidence-based treatment interventions, each DTx digital health product is created by fusing digital innovation with medical experience. We guarantee that every product is both legally compliant. Read More
SaMD, Digital Therapeutics
Medical disorders are treated, managed, and prevented with specialized therapy modalities. To deliver evidence-based treatment interventions, each DTx digital health product is created by fusing digital innovation with medical experience. We guarantee that every product is both legally compliant. Read More
Our work is trusted by leading medical and life science companies, empowering them to bring innovative and compliant platforms and AI solutions to the market.
Our work is trusted by leading medical and life science companies, empowering them to bring innovative and compliant platforms and AI solutions to the market.