Articles tagged with “medical-device-compliance”

EU Digital Omnibus: Pharma & Medical Device AI Compliance

Examine how the EU Digital Omnibus impacts pharma AI and medical device compliance. Review AI Act timeline extensions, MDR integration, and GDPR data updates.

40 min read

4/5/2026

eu digital omnibus eu ai act medical device compliance pharma ai mdr and ivdr regulatory compliance gdpr health data

EU AI Act High-Risk Compliance: Pharma & Medical Devices

An analysis of EU AI Act high-risk compliance for pharmaceutical and medical device AI. Covers MDR/IVDR integration, data governance, and 2026 deadlines.

35 min read

4/3/2026

eu ai act high-risk ai medical device compliance pharmaceutical ai mdr ivdr ai governance regulatory affairs

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

iec 62304 medical device software software lifecycle processes samd iso 14971 fda software guidance soup software medical device compliance

FDA Compliance Monitoring: A Guide to Top Software & Services

An educational review of top FDA compliance monitoring companies (updated March 2026). Compare leading QMS software platforms and expert regulatory consulting firms for pharma & medical devices, including QMSR/ISO 13485 transition guidance.

45 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