Qualix Belgium
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
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