MedTech WHITEPAPER
What you need to know BEFORE
Developing electronic medical devices
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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
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.
Our embedded electronics modules are fully compliant with requirements of IEC 60601-1 for safety and essential performance in medical devices.
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.