Understanding the Gaps and Overlaps Between ISO 13485, EU MDR, and MDSAP

Understanding the Gaps and Overlaps Between ISO 13485, EU MDR, and MDSAP

Quality Systems Now

Published on: 22/10/2025

ISO 13485, EU MDR, and MDSAP share significant commonalities in quality management, risk control, post-market surveillance, and documentation practices. However, gaps remain in clinical evaluation, UDI compliance, and jurisdiction-specific regulatory requirements.

ISO13485 Certification

Pathways to an ISO 13485 TGA A1 Audit Rating

Pathways to an ISO 13485 TGA A1 Audit Rating

Quality Systems Now

Published on: 19/05/2025

Pathways to an ISO 13485 TGA A1 Audit Rating

Therapeutic Goods Administration Quality Culture

Medical Devices in 2025 – ISO 13485 and ISO 14971

Medical Devices in 2025 – ISO 13485 and ISO 14971

Published on: 19/02/2025

Medical Devices in 2025 – ISO 13485 and ISO 14971

Medtech

Difficulty in maintaining control over compliance with GMP or ISO13485?

Difficulty in maintaining control over compliance with GMP or ISO13485?

Published on: 23/08/2024

Difficulty in Maintaining Control Over Compliance with GMP or ISO 13485: A Comprehensive Analysis

ISO13485 CertificationISO RecommendationsGMP