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.

A group of in-house professionals

A group of in-house advisors & 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.

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.

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.

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.

Expertise

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.

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.

Commercial, Market Access

Disease areas: Neuroscience, Mental Health, Cardiometabolic, Diabetes, Women’s Health, Oncology, Infectious Diseases, Rare Diseases.

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

Regulatory Compliance

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

Software Development

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

Quality Assurance

Aura Health clients’ project details and information are treated as confidential. To ensure privacy, we only share our project histories and client lists upon signing the NDA. Contact our colleague Hanna to get full access to our use case documentation.