SOFTWARE &
CYBERSECURITY

We develop software and data solutions for medical devices in line with IEC 62304 guidelines and deliver all necessary documentation for compliance.
Our software is fully tested and secure.

IEC 62304 COMPLIANT SOFTWARE

We are an Australia-based team of senior professionals with over 15 years of expertise in software development, data, and security solutions for MedTech and FinTech clients.

We’re bringing this experience and passion to Medical Device startups, helping them accelerate time-to-market with high-quality software and covering their compliance requirements for software and cybersecurity.

SERVICES WE PROVIDE

Our goal is to deliver a comprehensive service that will cover all your device software and compliance needs

Applications Development

Whether your device requires a web, mobile, or wearable application, our team will meet these needs with the most suitable tech stack.
Artificial Intelligence

Are you moving from one business system to another? Let us handle the data migration for you and ensure the data accuracy and integrity.
Data Integration

Are you looking for data consolidation and quality data models for your AI and analytical needs? We can help you migrate and integrate this data.
Firmware & IoT Development

Does your medical device need custom firmware? We develop Linux and Windows-based firmware and drivers for your requirements.
Data Visualisation

We build meaningful and insightful dashboards that could be embedded in your application. Any platform of your preference - we will deliver.
Cybersecurity

Penetration testing, cybersecurity assessments, and consulting – a complete cybersecurity documentation package compliant with FDA, TGA, and EU MDR requirements.

BOOK SESSION

WE MAKE OUR CLIENTS HAPPY

With us, you can be confident that your software is high-quality, secure, and fully compliant. We will support your submission.

Hight Quality

We are a boutique company that provides software development for medical device startups. Each member of our team has at least 15 years of experience. We like what we do.
Good Support

Our managers are always ready to answer your questions. You can call us during the weekends and at night. You can also visit our office for a personal consultation.
Nice Prices

We understand the financial constraints startups face, so we offer fixed pricing on standard services and we provide discounts for our regular clients. And we always overdeliver.
Individual Approach

Our company works according to the principle of individual approach to every client. This method allows us to achieve success in problems of all levels.
More Tan Dev Team

We will also help you connect with the right investors and support you with prototyping and presentations to make your pitch stand out.

RECENT PROJECTS:

SOFTWARE MODERNISATION

Our team successfully delivered a comprehensive software modernization and functionality enhancement project for a fundus camera device, addressing critical gaps in cybersecurity compliance. The legacy software lacked essential cybersecurity features, making the device vulnerable and non-compliant with current regulatory standards. We stepped in to develop the necessary components, upgraded outdated dependencies to newer, securely patched versions, and redeveloped several key modules to align with updated security protocols.

In addition, we meticulously prepared the software for a cybersecurity assessment, ensuring it met all stringent standards required by regulatory bodies. After extensive testing by an external cybersecurity team, the software passed with no issues found. Following these upgrades and assessments, the device achieved full regulatory approval, confirming it as secure, compliant, and ready for the market.

ARTIFICIAL INTELLIGENCE

Our team assisted with the development of an AI-powered SaMD (Software as a Medical Device) for processing and analyzing medical images. We designed and implemented a robust backend solution with cost-efficient data storage. As part of the implementation, we integrated the data into coherent, high-quality data models optimized for use by AI algorithms.

Our deliverables were meticulously documented according to IEC 62304 standards and included in the design history file within an ISO 13485-compliant Quality Management System. The software successfully met rigorous EU MDR requirements, including cybersecurity standards and the AI Act.

PATIENT PORTAL

For an asthma monitoring device, our team designed and developed a comprehensive app equipped with advanced analytics. This app allows caregivers to monitor and analyze critical patient indicators in real-time, receiving timely notifications for any irregularities or urgent alerts. This feature empowers caregivers to proactively manage patient health, ensuring quicker responses to asthma-related incidents.

A significant challenge in delivering this app was the requirement to replicate its logic and design seamlessly across both mobile and web platforms, ensuring a consistent user experience. To address this, we proposed an efficient solution that utilized cross-platform development tools, allowing us to maintain consistent functionality and aesthetics while optimizing development time and resources. This approach not only streamlined the user experience but also reduced long-term maintenance requirements for the client, making the app scalable and adaptable to future needs..

OUR LEADERS:

DENIS DMITRENKO

20+ years of experience in Software Development
5+ years of experience in the Medical Device Industry
Experienced Project and Test Manager
Software Architecture and Development Leader
ISO 27001 Auditor, IEC 62304 Developer, ISO 13485 Interpreter. Qualifications in Math, IT and Cybersecurity

VLAD ABRAMOV

20+ years of experience in IT and Data Analytics
4+ years of experience with AI
Data Modeler and Machine Learning Expert
Data Insights and KPI Analyst
Certified BI & AI Developer
Qualifications in Data and IT