NEWS
Understanding the Gaps and Overlaps Between ISO 13485, EU MDR, and MDSAP
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, UD... ...more
ISO13485 Certification
October 22, 2025•6 min read
Case Study: Establishing ISO 13485 and ISO 14971 Compliance
Case Study: Establishing ISO 13485 and ISO 14971 Compliance in a New Medical Device Manufacturing Facility ...more
ISO13485 Certification
September 23, 2025•5 min read
ISO13485:2016 – Quality Management Systems for Regulatory Purposes
ISO13485:2016 – Quality Management Systems for Regulatory Purposes ...more
ISO13485 Certification
July 14, 2025•6 min read
Identifying Gaps in Your GMP and ISO 13485 Compliance
Identifying Gaps in Your GMP and ISO 13485 Compliance ...more
ISO13485 Certification ,GMP
June 02, 2025•6 min read
Recent Developments for ISO 13485
Recent Developments for ISO 13485 ...more
ISO13485 Certification ,GMP &Medtech
January 01, 2025•3 min read
Compliance Readiness Assessment for GMP and ISO 13485
Compliance Readiness Assessment for GMP and ISO 13485 ...more
ISO13485 Certification ,GMP
December 02, 2024•5 min read
