Qualix’ team offers services related to regulatory affairs and quality management systems for medical devices.

Founder Ruth Beckers can count on multiple years of experience as quality and regulatory affairs support. Qualix provides companies with experience in the setup, implementation and daily management of quality management systems. Furthermore, they can assist during notified bodies and customers audits, and perform supplier audits. Qualix has been supporting many regulatory submissions from a wide variety of medical devices.

Qualix’ mission is to support organizations with obtaining a smooth regulatory approval and to construct a pragmatic and reliable quality system.

Services:

• Setup of Quality Management Systems (ISO13485 and ISO9001)
• Regulatory submission coordination and support
• Interim Quality /Regulatory management
• Audit assistance
• Training