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Medical Devices
Our MedTech manufacturing services
Circuitwise offers the most advanced manufacturing services for electronic assemblies certified to the ISO 13485 standard for medical devices.
Services include:
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Product development, in partnership with other ISO 13485 certified service providers
MedTech
Who we have worked with
Imaxeon supplies Bayer with cordless, mobile injectors used in CT scanning.
Visionflex provide products for remote health care that go beyond videoconferencing to facilitate comprehensive medical examinations.
Simavita manufactures smart diapers for both adults and infants, delivering a "time to change" alert function.
Nanosonics manufactures disinfection devices for probes in the ultrasound industry
Resmed is Australia's largest medical device manufacturer with a range of products treating sleep apnea, COPD and other chronic respiratory diseases.
This emergency ventilator was built in Australia by a consortium led by Grey Innovation. Read more.
Our ISO 13485 certification
Circuitwise Electronic Manufacturing is certified to the ISO 13485 standard for Medical Devices. This standard specifies the quality management systems required for regulatory purposes.
Circuitwise maintains all systems required to meet the standard including:
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Documentation: Our controlled document management system ensures that all records are captured from initial customer requirements to test reports on the final product.
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Management responsibility: The owners of Circuitwise cultivate a quality focused culture and all suppporting systems in its approach to business.
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Production and service provision: All of the business processes required to manufacture a medical grade electronic assembly are defined and controlled.
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Monitoring and measurement: Our medical grade testing and inspection system minimises defects, handles any non-conformities and ensures all equipment is maintained according to the standard.
For more information, view our Spotlight on ISO 13485 blog post and our quality systems page.
In addition, Circuitwise has Establishment Registration in the FDA's FURLS database making exporting products to the US easier.
Our rigorous traceability processes
One of the biggest regulatory burdens of medical device manufacturing is the need to keep track of every single activity undertaken to bring a device together and keeping records of every single measurement or test undertaken along the way.
Circuitwise takes away this burden for you with our powerful Cluso inventory management system, which tracks every single component coming from suppliers through to finals quality checks as we ship your assembled product to you. We send you all the information you need to complete your Device History File ready for quality audits.
For more information view our Component Traceability for Medical Devices page.
Our medical device partnerships
Circuitwise has partnered with a number of service providers who also have ISO 13485 certification. These providers complement our own services, delivering a complete MedTech product development and manufacturing capability.
Apart from electronics manufacturing, the key service providers that need ISO 13485 certification are:
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Industrial designer: Providing human-centered design services for the user interface, materials selection, housing and mechanical systems.
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Electronics designer: Providing electronic and software design services, delivering circuit designs, manufacturing instructions, electrical and functional testing devices and managing third party certification for electromagnetic compatibility.
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Sterilisation and packaging: Many medical devices require packaging design, sterilization of the device and sterile packaging.
We are able to form project partnerships with streamlined communication and provide assurance to the customer that all elements of the product life cycle are being addressed in an integrated way.
Customers have a choice of dealing with all the service providers in our project partnership separately or choosing one of them as a project lead. In the latter scenario, the lead service provider acts as a single point of contact, and manages all internal project communication on your behalf.
Industry participation
Circuitwise is a member of the Medical Technology Association of Australia. We support the association's aim of ensuring the benefits of modern, innovative and reliable medical technology are delivered effectively to provide better health outcomes for all Australians.
The MedTech industry is one of the strategic focus areas for NSW Smart Sensing Network (NSSN). The NSSN connects entrepreneurs to resarchers in advanced sensing technologies in most of the major universities.
Circuitwise supports the NSSN by hosting educational workshops for academic researchers on best practices in the commercialisation of electronics devices.
Circuitwise is proud to sponsor the NSW Active MedTech Community. This community is focused on making it easier to develop medical devices involving electronics and software. The community runs regular educational webinars and quarterly networking meetings.
Manufacturing a medical device
If you are new to medical device manufacturing, a great resource is the Australian Regulatory Guidelines for Medical Devices, published by the Australian Government Department of Health. The guideline outlines your regulatory responsibilities in detail.
Medical devices that include printed circuit board assemblies have special safety considerations because they are electrically powered. These considerations are covered in Section 13 - Active medical devices.
We have published a number of articles to assist you on your journey including:
Other good resources include Genesys' whitepaper on What you need to know BEFORE developing electronic medical devices and the many articles at Greenlight Guru.
