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UK COVID-19 Tests Regulation IMDRF

UK COVID-19 Tests Regulation

The Medical and Healthcare products Regulatory Agency (MHRA) of the UK has updated the information dedicated to tests and testing kits intended to detect the COVID-19. The information describes how the different types of COVID-19 tests operate and provides...

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IMDRF Guidance on Cybersecurity IMDRF

IMDRF Guidance on Cybersecurity

The International Medical Device Regulators Forum, a voluntary association of medical device regulating authorities focused on the improvement of the regulatory framework, issued guidance dedicated to the principles and practices for cybersecurity for medical devices....

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IMDRF Guidance on Requirements for CAB Assessors

The International Medical Device Regulators Forum (IMDRF), a voluntary association of national regulating authorities focused on the improvement of the medical device regulatory framework, published a proposal on competence and training requirements for regulatory...

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