Articles tagged with “iso-13485”

What is ISO 13485? A Guide to Medical Device QMS

Learn about ISO 13485:2016, the quality management system (QMS) standard for medical devices. This guide explains its requirements, purpose, and role in complia

45 min read

11/14/2025

iso 13485 quality management system medical devices regulatory compliance qms iso 13485:2016 fda qmsr eu mdr risk management

ISO 9001 in Biotech: A Guide to Relevance & Compliance

Is ISO 9001 still used in biotech? This guide analyzes how the QMS standard supports regulatory compliance, complements GMP, and improves quality in pharma & li

40 min read

11/13/2025

iso 9001:2015 biotechnology quality management system gmp regulatory compliance life sciences iso 13485 pharmaceutical quality