Quality Management System and Audits
From Regulatory Requirements to Operational Efficiency
We offer specialized guidance in developing and maintaining Quality Management Systems
aligned with ISO 13485, FDA 21 CFR part 820 (QSR/QMSR), MDSAP, and EU MDR requirements, transforming regulatory obligations into operational advantages.
QMS Establishment & Implementation
We build quality foundations tailored to your organization:
QMS establishment and implementation per ISO 13485, FDA 21 CFR part 820 (QSR/QMSR) and EU MDR requirements
Process mapping and improvement methodologies
Integration of EU MDR/ global regulatory requirements into existing systems
QMS training for organizational adoption and employee qualification
Audit Preparation & Management
We prepare your organization for successful regulatory audits:
Internal audit programs and assessments
Gap analysis against applicable standards
Mock audits to simulate regulatory inspections
Corrective action plans for identified issues
Audit response strategy and management
Our clients and partners
