QTICS Medical provides complex MDR/IVDR conformity support solutions for medical device manufacturers. Through its complex capabilities it acts as one stop shop integrating product development, regulatory consultancy, preclinical tests, clinical validation, software development and system certification capabilities.
- full spectrum MDR and IVDR regulatory support and training,
- FDA regulatory support,
- EN ISO13485:2016 quality management system implementation,
- safety and usability tests,
- biocompatibility tests,
- cybersecurity consulting and evaluation,
- clinical planning and trials,
- software development testing,
- embedded software development, PCB design
- quality system certification
- market access information through a wide international partner network
All these and other medical device related services in one place what are required for the MDR / IVDR CE conformity.
