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Expertvägledning om MDR-efterlevnad, harmoniserade standarder och regulatorisk strategi
Utvalda artiklar
IEC 62304 Software Safety Classification: A Complete Guide
Learn how to classify your medical device software as Class A, B, or C according to IEC 62304 requirements.
10 Most Common GSPR Gaps in Class IIb Medical Device Software
Based on analysis of 100+ compliance assessments, here are the most frequently missed MDR Annex I requirements.
Senaste artiklar
IEC 62304 Software Safety Classification: A Complete Guide
Learn how to classify your medical device software as Class A, B, or C according to IEC 62304 requirements.
10 Most Common GSPR Gaps in Class IIb Medical Device Software
Based on analysis of 100+ compliance assessments, here are the most frequently missed MDR Annex I requirements.
How to Prepare Technical Documentation for BSI Submission
Step-by-step guide to preparing your technical documentation package for British Standards Institution review.
ISO 14971:2019 vs 2007: Key Changes Every Medical Device Manufacturer Should Know
Comprehensive comparison of ISO 14971:2019 and the 2007 version, with practical guidance on transitioning your risk management process.
SOUP Evaluation Checklist for IEC 62304 Compliance
Complete checklist for evaluating Software of Unknown Provenance (SOUP) components in medical device software.