Impact of Technology Innovations on the Certification of Medical Imaging Devices
Hardware modifications to medical imaging devices typically can be addressed using existing standards, since requirements and radiation thresholds must still be followed. Software updates—to achieve clearer results or to reduce processing times—also fall within the scope of current medical standards, they don’t affect the general construction but can affect the essential performances.
But in cases where the hardware or configuration falls slightly outside the norm, a risk management report is required from the manufacturer to justify the decision and outline the associated risks.
While most imaging innovations can be certified under current standards, there are instances where modifications to current standards or the development of collateral standards must be established to address any new hazards.
This technical note explores the impact of technology innovations on the certification of medical imaging devices.
This technical note covers the following topics:
- Factors driving the growth of the medical device market;
- Current standards that address the safety and performance of medical imaging devices;
- New technologies that may require modifications to current standards, including artificial intelligence, machine learning and deep learning, quantum sensors, and multi-usage systems; and
- How CSA Group is working with companies to certify medical imaging devices.
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