Qualix

Your partner in Quality Assurance & Regulatory Affairs

• QMS: Set up, implement and/or modify your Quality Management System (QMS) according to ISO13485
• Regulatory Affairs: Support you in your regulatory process (CE marking, FDA)
• Audit assistance: Support you during notified body audits or guide you in auditing your subcontractors
• Interim QA/RA: Act as your Quality Assurance or Regulatory Affairs manager