Quality

Noris Medical invests significant resources in creating an environment for the design and manufacture of its dental products. Keeping patient safety at the forefront throughout the process, Noris Medical complies with international standards for manufacturing and quality. The entire manufacturing process is monitored and recorded for total process traceability. All facilities are subjected to strict inspection procedures.

 

  • Products carry the CE mark and meet the European Medical Device Directive (93/42/EEC).
  • Products received the FDA Clearance Premarket Notification (510k) (K140440, K153043, K151909).
  • Meticulous quality control system is in compliance with ISO 9001:2008, EN ISO 13485:2012 and FDA QSR 21 CFR Part 820.
  • Facilities are subject to routine audits by international auditors.
  • Class 10,000 Clean Room for production.