Consulting, auditing and training in medical device quality
Expertise dedicated to medical device manufacturers
In a sector where technical and regulatory requirements are extremely demanding, medical device manufacturers must combine responsiveness, control and compliance.
At Qalia Performance, we support your projects to turn constraints into drivers of performance, reliability and market value.
Regulatory Consulting & Support
We intervene at every stage of your projects to secure your quality and regulatory activities:
● Implementation, optimisation or evolution of your QMS
● Technical file analysis and development
● Regulatory strategy design tailored to your products and maturity
● Support in France and internationally
Our approach combines regulatory rigour with adaptation to your operational needs.
Internal Audits and Inspection Readiness
We conduct targeted audits to strengthen compliance and anticipate regulator expectations:
- Internal audits
- Supplier audits
- Mock audits in preparation for certification
Our audits combine:
- Constructive posture
- Methodological rigour
- Clear, concrete and immediately usable deliverables
Specialised Professional Training
We offer training tailored to the quality and regulatory challenges of the medical device industry.
Examples:
- ISO 13485 Quality Management System
- Metrology applied to medical devices
- Risk management
- Process validation
- Regulatory requirements
Our training is designed around your needs with interactive, operational learning.
Why choose Qalia for your medical device projects?
- Expertise in key industry standards (ISO 13485)
- Ability to combine regulatory compliance with industrial performance
- Pragmatic, customised support aligned with your needs