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
Case Study: Establishing ISO 13485 and ISO 14971 Compliance

Case Study: Establishing ISO 13485 and ISO 14971 Compliance

Quality Systems Now
Published on: 23/09/2025

Case Study: Establishing ISO 13485 and ISO 14971 Compliance in a New Medical Device Manufacturing Facility

ISO13485 Certification
ISO13485:2016 – Quality Management Systems for Regulatory Purposes

ISO13485:2016 – Quality Management Systems for Regulatory Purposes

Quality Systems Now
Published on: 14/07/2025

ISO13485:2016 – Quality Management Systems for Regulatory Purposes

ISO13485 Certification
Identifying Gaps in Your GMP and ISO 13485 Compliance

Identifying Gaps in Your GMP and ISO 13485 Compliance

Quality Systems Now
Published on: 02/06/2025

Identifying Gaps in Your GMP and ISO 13485 Compliance

ISO13485 CertificationGMP