Matthias Marivoet

Senior Quality Management Expert

Matthias is a Senior Quality Management Expert at QbD Group, helping life science companies design and maintain robust quality management systems aligned with GxP requirements.

4 articles

Quality AssuranceSep 5, 2025 6 min

QMSR for Startups: What to Do Before February 2, 2026

Get inspection ready for FDA’s QMSR by Feb 2, 2026. See the ISO 13485 gaps, phased timeline, and quick checklist every medtech startup needs.

Quality AssuranceFeb 6, 2025 4 min

Adelántate al cumplimiento de la normativa: Cómo gestionar eficazmente tus auditorías anuales

Gestiona auditorías anuales para garantizar el cumplimiento y la calidad en productos farmacéuticos y dispositivos médicos. ¡Aprende estrategias clave y mejora tu QMS ahora!

Quality AssuranceSep 5, 2024 4 min

Stay Ahead of Compliance: How to Effectively Manage Your Yearly Audits

Manage yearly audits to ensure compliance and quality in pharma and medical devices. Learn key strategies and boost your QMS now!

Quality AssuranceApr 9, 2024 5 min

FDA’s QMSR Introduction: Aligning Device CGMP Regulations with ISO 13485:2016

Explore the FDA's final rule integrating ISO 13485:2016 into QMSR for medical devices. Understand impacts on manufacturers and how to comply by 2026.

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