Quality Management Systems & Regulatory Compliance
Quality Management Systems & Regulatory Compliance
Building Effective, Efficient, and Compliant Quality Management Systems
A robust quality management system provides the foundation for controlled processes, traceable decisions, and continuous improvement in product and process quality.
Avary Consulting supports companies in assessing, developing, and optimizing their quality management systems.
For medical device and IVD manufacturers, we consider the requirements of ISO 13485:2016, the EU Medical Device Regulation (EU) 2017/745 (MDR), and the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR).
For the U.S. market, we incorporate the requirements of the FDA Quality Management System Regulation (QMSR), 21 CFR Part 820, which became effective on February 2, 2026, and incorporates ISO 13485:2016 by reference.
For pharmaceutical manufacturing and quality operations, we consider applicable EU Good Manufacturing Practice (GMP) guidelines, particularly Chapter 1 on Pharmaceutical Quality Systems, as well as relevant principles from ICH Q9(R1) on Quality Risk Management and ICH Q10 on Pharmaceutical Quality Systems.
Our services include:
- Assessment and evaluation of existing quality management systems
- QMS gap assessments
- Optimization of quality processes and cross-functional interfaces
- Development of risk-based quality strategies
- Documentation and process improvement
- Preparation for audits and regulatory inspections
- Development and coordination of appropriate remediation activities
- Support for continuous improvement of QMS effectiveness
Your Business Value: A transparent, practical, and effective quality management system that integrates regulatory compliance with operational efficiency.