About
Qualix is your partner for Quality, Clinical and Regulatory Affairs. We assist medical devices manufacturers in different domains: - Setup, modification and maintenance of Quality Management Systems according to quality system standards (ISO 13485, 21 CFR 820, EU MDR 2017/745, EU IVDR 2017/746) - Guidance during regulatory documentation writing and submission - Support during audits (internal and external) - Act as your QA/RA manager and/or PRRC
Technologies
OutlookMicrosoft Office 365ApacheMobile FriendlyBootstrap FrameworkGoogle Font APIAzure DevopsCircleMicroAIDeel
Keywords
iec 62304aiclinical evaluationmdrmddce markingiso 13485steam sterilizationiso9001 & mddiso9001ivdreo sterilizationmedical device regulationqmsiso1348521 cfr 820iso14971medical equipment manufacturingmedical devicesquality management consultingaudit assistancemedical device certificationsubcontractor audit guidanceregulatory process guidanceservicesqms setuptesting laboratories and servicesqms modificationfda supportregulatory audit support
Company Information
- Employees2
Location
Leuven, Flanders, Belgium
