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MEDTECH WHITEPAPER
What you need to know BEFORE
Developing electronic medical devices
Thanks for your interest in our MedTech whitepaper! Now that we have confirmed your email address, please download the whitepaper by clicking on the PDF dowload button.
To learn more, attend the webinars and networking events of the:
The purpose of this community is saving and improving lives by making it easier to develop medical devices with electronics and software. For more information visit the community at
https://www.nswactivemedtech.com.au/.
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Find out more about what we do
Our MedTech projects
Cervical cancer screening
Hand trauma therapy
CT Injection system
Why you should choose Genesys
Specialists in electronics for Medtech
With more then 20 specialist engineers in MedTech certified software and hardware design, we are the Go To product development firm in Australia
Integrated
design and
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.
One Pass to Production –
Guaranteed!
We are the only company in Australia to guarantee that we will deliver a working prototype first time, or we will make good at our own expense. This eliminates your risk of cost over-runs.
Our MedTech partners
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.your own text and edit me. It's easy.
Medical sensing
expertise
We have experience in sensing a range of medical paremeters including physiological waveforms, body temperature, body movement, EEG, ECG and SP02.
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.
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.
patient safety
Our embedded electronics modules are fully compliant with requirements of IEC 60601-1 for safety and essential performance in medical devices.your own text and edit me. It's easy.
Medical engineering standards
Genesys is expert in the design of a product to the following standards:
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Quality Systems ( ISO 13485): This 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.
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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.
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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.
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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.
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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.
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For more information view the full list of standards we regularly deal with.
