Articles tagged with “medical-device-compliance”

IEC 62304 Guide: Medical Device Software Safety Standard

Explore the IEC 62304 standard for medical device software. Learn about safety classifications, lifecycle processes, and compliance for FDA and EU MDR.

65 min read

2/1/2026

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FDA Compliance Monitoring: A Guide to Top Software & Services

An educational review of top FDA compliance monitoring companies. Compare leading QMS software platforms and expert regulatory consulting firms for pharma & med

40 min read

11/16/2025

fda compliance qms software regulatory consulting quality management system cgmp compliance 21 cfr part 11 medical device compliance life sciences