Going a Bit Further
in HealthTech
Australian Vision, German Precision, Compliance Mastery -Your Partner for Medical Software in Australia and Beyond.
Compliance and Innovation Hand in Hand
Our holistic approach merges stringent regulatory compliance with cutting-edge innovation, shaping the future of Software as a Medical Device (SaMD). We specialize in developing mobile applications and complex backend systems that not only meet but exceed regulatory requirements across Australia, Europe, and the USA. By safeguarding data and enhancing patient care, we push the limits of HealthTech. Together, we navigate TGA, FDA, and MDR regulations to craft software that's not merely compliant but truly revolutionary.
Precision in Every Code
Unmatched accuracy and reliability in our software designs.
Regulatory Compliance Guaranteed
Precision-engineered solutions navigating healthcare regulations with ease.
Frontier of Innovation
Explore new realms of HealthTech possibilities with us.
Facing the labyrinth of SaMD regulations across regions?
9bit Concept stands as your beacon through the regulatory maze, merging innovation with compliance. Our bespoke project teams of seasoned developers and regulatory experts ensure your SaMD thrives under TGA, FDA, and MDR requirements, propelling your projects forward with our comprehensive expertise.
Simplifying SaMD Regulations
Our Expertise Unveiled
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Tailored Mobile Applications: Designed for optimal user engagement and patient care.
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Seamless Web Applications: Integrating effortlessly with healthcare ecosystems for robust data access.
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Reliable Desktop Applications: Secure access to medical data where it matters most.
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Advanced Backend Systems: Powering the next generation of medical software with innovative backend solutions.
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Adherence to global security protocols, ensuring patient data protection at every level.
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Comprehensive penetration testing and security management practices to fortify software.
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Full compliance with GDPR and other data privacy laws, safeguarding information across jurisdictions.
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Upholding the highest standards with ISO 13485 and IEC 62304 for quality management and software lifecycle processes.
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Anticipating and mitigating risks with proactive strategies aligned with ISO 14971.
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Ensuring intuitive, accessible, and user-friendly software through usability engineering (IEC 62366).
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Expert navigation through medical device approval complexities and market positioning.
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Thorough implementation of critical MDR, FDA, and TGA requirements, from concept to commercialization.
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Features for Tomorrow’s HealthTech
Agile development within an ISO-compliant framework.
Cloud-based solutions and Atlassian product documentation for unparalleled project management and documentation.
Expertise in Angular, React, Flutter, Native Apps, AWS, GCP, Kubernetes, and the Java ecosystem, ensuring the best technology stack for your project.
Streamlining Your Path to Innovation
