QUALITY MANAGEMENT SYSTEM (QMS) PRIMER
The QMS Primer is provided by SeerPharma and is supported and fully funded by the REDI initiative, powered by MTPConnect so there is no...
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Jul 20, 20221 min read
OCT 2021 GOOD MACHINE LEARNING PRACTICE FOR MEDICAL DEVICE DEVELOPMENT: GUIDING PRINCIPLES
The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency...
Jul 20, 20221 min read
FEB 2022 REGULATORY CONSIDERATIONS FOR SOFTWARE AS A MEDICAL DEVICE
Why authorities will soon be paying closer attention to software – and what SaMD manufacturers should be doing now.
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