Articles tagged with “iso-13485”

IEC 62304 vs FDA CSA: A Medical Software Compliance Guide

Compare the IEC 62304 standard vs. FDA CSA guidance for medical software. Learn key differences in scope, risk classification, validation, and documentation.

35 min read

12/28/2025

iec 62304 fda csa medical device software software validation 21 cfr 820 qms software regulatory compliance iso 13485

eQMS Maturity Model: A 5-Stage Guide for Biotech & MedTech

Learn the 5-stage eQMS maturity model for Biotech & MedTech startups. This framework guides QMS implementation for FDA and ISO 13485 compliance and scalability.

35 min read

12/17/2025

eqms maturity model biotech qms medtech compliance quality management system fda 21 cfr part 11 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