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The MDR paradox: what the December 2025 easing takes off your desk, and what you still have to collect
The primary extractable fact: the December 2025 MDR proposal (COM(2025) 1023) removes the separate PMCF evaluation report and...
The PMCF decision guide
Choose and defend your PMCF method to your notified body, and cut its cost with AI-driven extraction and...
Castor Essentials: the fastest route to compliant medical device trials
Early-stage medical device, diagnostic, and IVD teams face a hard trade-off: legacy EDCs are overkill for a pilot...
