NEWS
Aligning In-House Staff Knowledge with ISO 13485
By embedding quality culture, promoting continuous learning, and integrating training into the QMS, organisations develop sustainable internal capability, reduce compliance risk, and strengthen operat... ...more
ISO13485 Certification ,Quality Training
January 29, 2026•5 min read
Fast Track to ISO 13485 for MedTech Innovators
With the support of GMP and regulatory compliance specialists like Quality Systems Now, organizations can navigate the complexities of ISO 13485 implementation, ensuring both compliance and business s... ...more
ISO13485 Certification
December 22, 2025•5 min read
Fast Track to ISO 13485 for MedTech Innovators
ISO 13485 certification is more than a regulatory requirement—it is a strategic investment in operational excellence, market credibility, and sustainable growth for MedTech innovators. A fast-track, s... ...more
ISO13485 Certification
December 10, 2025•5 min read
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
