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Compliance
Launch with compliance; EU MDR
FDA’s New Lens on AI/ML Devices
Artificial intelligence and machine learning (AI/ML) are no longer “future trends” in Medtech, they are here, and the FDA is moving...
Nathan Piland
Aug 282 min read
Is it a DHF, Medical Device File or Technical File?
Medical Device File is a term used by ISO 13485, similar but different than a DHF and a Technical File for EU Submission
Nathan Piland
Oct 12, 20234 min read
Mastering Clinical Evaluation for EU MDR Compliance: A Summary Guide
Delving into one crucial aspect of EU MDR compliance: Clinical Evaluation
Nathan Piland
Aug 21, 20232 min read
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