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Medical Technologies
Integrated MedTech Design Services
End-to-end product realisation for medical technologies.
Genesys delivers integrated electronics and software design services for medical devices, supporting companies from early concept through to commercial manufacturing. Through Genesys Medical Devices and our strategic partners, we provide true whole-of-product development, combining engineering, regulatory, and manufacturing expertise under one coordinated team.
Our MedTech capabilities include:​
​Core Engineering
• Medical App Development (SaMD and device-integrated apps)
• Design and development (whole-of-product)
​Regulatory & Quality
• Regulatory strategy and compliance
• Regulatory compliance technical support for electronics and software
• Usability engineering
• Quality management systems
• Clinical trials support
​Commercialisation & Manufacturing
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• Industrial design
• Commercialisation planning
• Intellectual property support
• Sterilisation and packaging
• Electronics manufacturing
• Contract (box-build) manufacturing and supply chain
• Project management
Planning a medical device with electronics or software?
Download our Whitepaper on What You Need to Know before Developing Electronic Medical Devices.
Our Medical Device Certification
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Genesys is certified in the ISO 13485 quality standard for electronics hardware and software development for Medical Devices. This means you can be assured that our designed will meet regulatory requirements globally.
ISO 13485
QUALITY
MANAGEMENT
SYSTEMS
International standard defining the quality management requirements for medical device design and development, ensuring controlled, compliant, and traceable processes.
ISO 14971
RISK
MANAGEMENT
Standard governing the identification, evaluation, and mitigation of risks to ensure patient and operator safety throughout the device lifecycle
IEC 60601-1 SAFETY AND ESSENTIAL PERFORMANCE
Core safety standard for medical electrical equipment, addressing electrical safety and ensuring devices perform their intended medical function without unacceptable risk
IEC 62366 USABILITY
ENGINEERING
Standard focused on designing medical devices that minimize use errors and improve safety through structured human factors and usability engineering
IEC 62304 MEDICAL DEVICE
SOFTWARE
LIFECYCLE
Standard defining the lifecycle requirements for medical device software, including development, verification, validation, and traceability
Introducing the Genesys Medical
Wireless Wearable Sensor platform
Genesys has developed a secure Bluetooth enabled platform for real time sensor data capture and seamless integration with companion mobile applications.
Our architecture provides the complete hardware and firmware foundation, enabling easy integration of custom sensors alongside our built in modules. This allows your team to focus on user experience and clinical outcomes.
Developed under medical device design controls, the platform supports a faster and more efficient pathway to regulatory compliance.
Medical Mobile App Development
We develop medical Apps optimised for integration with medical devices, delivering the user interface, application logic and all the support facilities.
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By building your App on top of our template, all of the under-the-hood facilities around navigation, user management, gathering device data, graphical data display, cybersecurity and data integrity come out-of-the box.
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By using our modularised software and templates developed under medical device design controls and addressing issues of using an uncontrolled mobile device platform, we make your regulatory compliance tasks much easier.
Our MedTech Case Studies
This advanced dosimetry system aims to enhance the accuracy and precision of radiation therapy, preventing acute skin and tissue damage. A sensor patch is inserted into a hub for transmitting data to a mobile App.
Salient is a system for controlling injection of contrast media such as radio-opaque dye for patients undergoing CT examinations. It is cordless and compact, with a user friendly touch screen interface.
This handheld system uses AI technology to help prevent the 300,000 annual deaths due to cervical cancer through the real-time detection of pre-cancerous and cancerous cells
The Permanence is a system for applying current to hair follicles, permanently killing them. The control system allows for operation of 16 probes simultaneously, treating 200 hairs per hour.
Following neuro/spinal surgery, this proof-of-concept device from WAGAR analyses the gait of recovering patients and provides warning of complications requiring follow up interventions.
Genesys works with a range of strategic partners to cover every aspect of your MedTech project. You are free to bring your own preferred partners to any project. The following are just some of the companies we recommend:
Ready to turn your medical innovation into a compliant, market-ready product?
"From Cloud Connectivity to IoT Innovation, Genesys leverages AWS Partner Solutions to deliver future-ready technology for businesses"