RegDesk Regulatory Roundup

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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IMDRF Proposed Principles of IVD Classification

The International Medical Device Regulators Forum (IMDRF), an association composed of medical device regulating authorities, proposed new principles of classification of the in vitro diagnostic medical devices. The organization itself is focused on the development and...

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IMDRF Clinical Guidelines Uncategorized

IMDRF Clinical Guidelines

The International Medical Device Regulators Forum (IMDRF) has released guidelines on clinical evaluations, clinical investigations, and clinical evidence for medical devices. These documents replaced the previous documents that regulated the same areas as issued by...

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