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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 Catalyst is the first to market to show industry-leading data extraction accuracy in a sponsor-audit-friendly technical approach
Castor Catalyst, Castor's AI-driven clinical data platform, reads data directly from source records and proposes each value for...
How device and diagnostic teams run compliant studies without enterprise EDC overhead
Medical device, diagnostic, and IVD teams face a hard trade-off. Enterprise EDC systems bring cost and build time...
What nine years of MDR experience is changing about PMCF planning, and where AI fits in
Nine years into EU MDR, the conversation has moved past "how do we collect PMCF data" to a...
PMCF requirements are raising hard questions about cost, device viability, and where AI fits in
Most PMCF programs weren't designed for EU MDR. They were built before Article 61(11) made ongoing clinical data...
How MMI Leveraged Castor to Fulfill MDR Requirements for Their Groundbreaking Microsurgery Robot
Castor provided MMI with a compliant, user-friendly platform that was able to enhance enrollment by over 500% and...
