Life sciences consulting
Life sciences consulting
Specializing in medical devices, we develop regulated products driven by our commitment to improving people’s lives. With our headquarters in Croatia and a global perspective, we deliver high-quality digital health products.
Specializing in medical devices, we develop regulated products driven by our commitment to improving people’s lives. With our headquarters in Croatia and a global perspective, we deliver high-quality digital health products.
A group of in-house professionals
A group of in-house advisors & experts
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.
Commercial Strategy
By refining market positioning, optimizing business models, and tailoring marketing approaches, we help organizations stand out through in-depth market analysis, identification of competitive advantages, and strategic growth levers. To drive measurable success, we also support teams with presentation development, coaching, and business development.
Market Access
Once the market study is complete and the value proposition is defined, we help our clients by developing innovative business models, assessing market potential, analyzing regulatory changes (including reimbursement and health economics), mapping key players, and cultivating collaborative partnerships (public/private, insurers, etc.).
Clinical Research
Our QMS, based on ISO 14155 and ISO 20916, is specially tailored to the requirements for clinical investigations of medical devices to ensure the protection of human rights, avoidance of error, and worldwide acceptance of the study results. With our experience in global medical device studies, we will guide you through every step to ensure your study’s successful completion.
Health Economics and Outcomes Research
Our HEOR specialists analyze clinical, economic, and patient-reported data to assess the value of healthcare interventions. By integrating cost-effectiveness, budget impact, and quality-of-life considerations, we help stakeholders—including payers, providers, and patients—make evidence-based decisions about product adoption and reimbursement.
Leadership
Leadership
Our management team is responsible for the strategic direction, supervision of the performance of the company, and digital health strategy implementation.
Standards and certifications
Standards and certifications
Our ISO-13485 certification means that our development activities are controlled and structured by audited and certified processes. These ensure the highest quality of service and the satisfaction of life science partners.
Our ISO-13485 certification means that our development activities are controlled and structured by audited and certified processes. These ensure the highest quality of service and the satisfaction of life science partners.
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
The Health Insurance Portability and Accountability Act (HIPAA) of 1996 establishes federal standards protecting sensitive health information from disclosure without a patient’s consent.
GDPR
General Data Protection Regulation (EU) 2016/679
Capabilities
Capabilities
Our highly skilled medical software technology developers work across every modern framework and language. Our experience in life sciences equips engineers to anticipate technology risks and help clients build optimized applications.
Our highly skilled medical software technology developers work across every modern framework and language. Our experience in life sciences equips engineers to anticipate technology risks and help clients build optimized applications.
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
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 maturing products. Read More
Digital Healthcare
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
Clinical Research Trials
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
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
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 maturing products. Read More
Digital Healthcare
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
Clinical Research Trials
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