SQA
MAY 17, 2022
Requirements for classification and related issues established under RDC 185/2001, as well as other relevant medical device regulations, will apply for SaMD, as well. United States Food and Drug Administration (FDA) – Regulations and Guidances. United States Food and Drug Administration (FDA) – Recalls.
SQA
SEPTEMBER 2, 2022
The new guidance from the European Medical Device Coordination Group (MDCG) covers “borderline products” not easily categorized either as medical devices falling under MDR requirements or medical products for human use falling under Directive 2001/83/EC (MPD) requirements for CE Marking.
Hall Render
JULY 14, 2023
How did we get here? Nonprofit hospitals under growing scrutiny over how they justify billions in tax breaks States increase pressure on nonprofit hospitals as charity care scrutinized Senate proposal would give hospitals $385M for emergency preparedness.
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