.png)
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
​
• 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
​
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.
Introducing the Genesys Medical
Wireless Wearable Sensor platform
Genesys has developed a wireless Bluetooth connected platform for logging sensor data and wirelessly egressing it to a companion mobile App.
​
The platform provides all the "under-the-hood" hardware and software enablers while making it easy to add your specific or custom sensors to the common/standard in-built ones we provide. This allows you to focus on your end user requirements.
​
Our baseboard and firmware enablers have been developed under medical device design controls which will accelerate your 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.
​
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.
​
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
Radiation dosimeter
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.
Contrast media injection for CT scans
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.
Cervical cancer screening
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
Electrolysis hair removal
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.
Gait analysis monitor
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.
Why Choose Genesys?
SPECIALISTS IN ELECTRONICS FOR MEDTECH
With more than 15 specialist engineers in MedTech certified software and hardware design, we are the Go To product development firm in Australia
INTEGRATED DESIGN & COMPLIANCE
Regulatory consultants will tell you WHAT you need to do. We tell you HOW it should be done – fully integrating the technical implementation with all necessary compliance steps.
IEC 62304 COMPLIANT SOFTWARE LIBRARY
Genesys has developed a library of hardware and software modules that are already compliant with the IEC 62304 medical software standard. This proven library delivers unparalled reliability.
Our Medical Technologies
Genesys has a library of technologies that apply in a range of health industry sectors. See our white labelling service to have the following example applications adapted for your business, with full ISO 13485 certification.
IEC 60601-1 COMPLIANT HARDWARE
Our embedded electronics modules are fully compliant with requirements of IEC 60601-1 for safety and essential performance in medical devices.
IEC 62304 MEDICAL SOFTWARE
Genesys has a library of software modules compliant with the IEC 62304 medical software standard. This enable us to develop embedded firmware or standalone medical software.
PATIENT
SAFETY
Our embedded electronics modules are fully compliant with requirements of IEC 60601-1 for safety and essential performance in medical devices.
MEDICAL SENSING EXPERTISE
We have experience in sensing a range of medical parameters including physiological waveforms, body temperature, body movement, EEG, ECG and SP02.
HEALTH DATA MANAGEMENT
Our technologies can analyse data in the device or securely deliver it to the cloud. We handle the stringent requirement for patient privacy and data integrity using encryption and checksum technologies.
Medical Engineering Standards
Genesys is expert in the design of a product to the following standards:
-
Quality Systems ( ISO 13485): This is the overarching quality standard system that guides product development for medical devices. Everyone involved in the product's development needs to be certified to the standard or audited by someone that is. Genesys is ISO 13485 certified for medical device electronics hardware and software development.
​
-
Risk management and hazard analysis (ISO 14971): This standard covers the application of risk management to medical devices, particularly as it relates to patient and operator safety. It primarily involves identification of hazards and mitigating risk. Safety by design and other protective measures are key risk management features, as well as the use of information, labeling, warnings and training resources.
​
-
Safety and essential performance (IEC 60601-1): While much of this series of technical standards for medical electrical equipment relates to safety, the requirements for essential performance cut to the heart of the device's ability to carry out the medical functions effectively without creating unacceptable risk. Determining the risks associated with the essential performance of a device can be much more challenging than determining basic electrical safety requirements which are usually set out in other standards.
​
-
Usability engineering (IEC 62366): This standard covers the application of usability engineering to medical devices. Usability covers both the potential for error in the device's use and the ease of using the device for its intended purpose. Unique to every device, the scope of usability covers everything from the physical form of the device and its mechanical operation to clarity of labeling and graphical interfaces.
​
-
Software development (IEC62304): This standard specifies the requirements for firmware and software in medical devices at every stage of the product's life cycle. Of critical importance is the traceability of user requirements. Note that standalone software can be classed as a medical device if it has a medical purpose.