Idea to market consultancy for SaMD and AI medical devices
Idea to market consultancy for SaMD and AI medical devices
Headquartered in the beautiful city of Zagreb, Croatia, we ensure your SaMD or AI medical device moves with precision from design to approval and adoption.
Headquartered in the beautiful city of Zagreb, Croatia, we ensure your SaMD or AI medical device moves with precision from design to approval and adoption.
A global team of HealthTech experts
A global team of HealthTech experts
Medical Affairs
Regulatory Affairs
An accredited RA partner providing consulting services for the complete lifecycle of SaMD and AI 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 SaMD and AI medical device product evaluation, approval, and regulatory compliance.
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
Our HEOR experts evaluate clinical, economic, and patient-reported data to demonstrate the value of healthcare interventions. By combining cost-effectiveness analysis, budget impact assessment, and quality-of-life outcomes, we generate the evidence that payers, providers, and patients need to make informed decisions on product adoption and reimbursement.
Intellectual Property
We support innovators in securing patents, software, algorithms, and designs while developing comprehensive IP strategies to minimize legal and market risks. We provide guidance through patent applications, international protection, and portfolio management, combined with continuous monitoring to ensure your competitive advantage.
Software, AI Medical Device Development
We help transform innovative ideas into compliant, high-quality SaMD and AI solutions that deliver real value to patients, providers, and the life sciences ecosystem. Drawing on deep expertise in technology, regulatory pathways, and clinical validation, our team supports you through every stage of development.
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
ISO 20417:2026
Medical devices — Information to be supplied by the manufacturer
ISO 14155:2026
Clinical investigation of medical devices for human subjects — Good clinical practice
GAMP 5
A risk-based approach to compliant GxP Computerized system
HIPAA
Health Insurance Portability and Accountability Act
GDPR
General Data Protection Regulation (EU) 2016/679
A legal framework in the European Union that regulates data protection and privacy for individuals within the EU and EEA, while also overseeing the transfer of personal data outside these regions.