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Novaspine

Corporate Compliance

Quality Management System

NovaSpine is dedicated to ensuring the highest level of compliance with applicable laws and international standards. Our quality system in compliance with standard ISO 13485 was developed to maintain the highest level of quality, control, surveillance, and most importantly, of patient safety.

NovaSpine Quality Management System Certificate

Products

All medical devices manufactured by NovaSpine are designed with passion and CE marked to ensure safe and reliable solutions for users.

NovaSpine CE Certificates

Non-sterile devices CE marked under the MDD 93/42/EEC

Sterile devices CE marked under the MDD 93/42/EEC
3D Printed devices CE marked under the MDD 93/42/EEC

Letter of extension of validity of MDD 93/42/EEC Certificates

SOCORE, MATRIS & Instruments devices, CE marked under the EU MDR 2017/745 (certificate MDR 00053-C)

DIVA devices, CE marked under the EU MDR 2017/745
(certificates MDR 00053-A, MDR 00053-B & MDR 00053-C)