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Idea to market consultancy for medical devices

Idea to market consultancy for medical devices​

Headquartered in the beautiful city of Zagreb, Croatia, we ensure your AI medical device moves seamlessly from design to approval and adoption.

Headquartered in the beautiful city of Zagreb, Croatia, we ensure your AI medical device moves seamlessly from design to approval and adoption.

Full-cycle AI and medical device consultancy in Zagreb, Croatia.

A global team of experts

A global team of experts

Medical Affairs

Our medical affairs support pharmaceutical and biotechnology companies in publication planning and scientific communication, collaborate on research assistance, offer peer-to-peer scientific exchange, and disseminate medical information.

 

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.

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 medical software and AI solutions that deliver real value to patients, providers, and the life sciences ecosystem. Drawing on deep expertise in technlogy, 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.

Ivan Biocic

Chief Executive Officer

Aaron Berger

Chief Technology Officer

Kety Mirkovic Kos

Director of Clinical Research

Saray Ugidos Semán

Head of Quality, Regulatory, and Clinical Affairs

Ivan Biocic

Chief Executive Officer

Aaron Berger

Chief Technology Officer

Saray Ugidos

Head of Quality, Regulatory, and Clinical Affairs

Kety Mirkovic Kos

Director of Clinical Research

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

This standard outlines the requirements for a medical device–specific quality management system. Safety and quality are non-negotiable, which is why we hold a 13485:2016 certificate.

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

Our quality management system utilizes IEC 62304 as a guiding framework across all stages of the software life cycle.

IEC 82304

Health Software Product Safety

This standard addresses the safety and security of stand-alone health software products, referencing ISO 14971 and IEC 62304 for risk management and software lifecycle processes. It applies to both medical device software and other health software solutions.

UL-2900-2-1

Software Cybersecurity

Aura Health follows these guidelines to address specific cybersecurity risks and maintain ongoing vigilance regarding cybersecurity threats in connected devices.

IEC 62366

Medical Device Usability

Relevant aspects of the standard are applied throughout our risk management processes and UI/UX design.

GAMP 5

A risk-based approach to compliant GxP Computerized system

By adopting ISPE’s GAMP5 framework, Aura Health effectively guides the development of GxP-critical computerized systems while aligning with international standards such as ISO 13485, IEC 62304, and ISO 14971. This integrated approach ensures each phase of our product lifecycle meets stringent industry and regulatory requirements for quality, safety, and security.

ISO 20916:2019

In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

ISO 20916 defines GSP and provides a framework of what that means for clinical performance studies. The guideline describes how to plan, design, conduct, record, and report clinical performance studies that aim to assess the performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes.

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

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.

Get in touch with our experts

Get in touch with our experts