Qualix is your partner for Quality Assurance and Regulatory Affairs.
We assist medical devices manufacturers in different domains:
– Setup, modification and maintenance of Quality Management Systems according to quality system standards
– Guidance during technical file setup for CE marking
– Support during audits (internal and external)
– Act as your QA/RA manager
Company’s Keywords:
iso9001, iso13485, mdd, ce marking, iso14971, eo sterilization, steam sterilization
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