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
Outlook
Microsoft Office 365
Apache
Mobile Friendly
Bootstrap Framework
Google Font API
Azure Devops
Circle
Micro
AI
Deel
Keywords
iec 62304
ai
clinical evaluation
mdr
mdd
ce marking
iso 13485
steam sterilization
iso9001 & mdd
iso9001
ivdr
eo sterilization
medical device regulation
qms
iso13485
21 cfr 820
iso14971
medical equipment manufacturing
medical devices
quality management consulting
audit assistance
medical device certification
subcontractor audit guidance
regulatory process guidance
services
qms setup
testing laboratories and services
qms modification
fda support
regulatory audit support
Company Information
-
Employees 2
Location
Leuven, Flanders, Belgium
