Beyond Certification

We are strengthening our focus on the environment, quality, health and safety.

We are proud to announce that we have passed our ISO audit and have been awarded the ISO 14001 & ISO 45001 certificates for the Environment, Health & Safety standards.

We are an ambitious and responsible company that takes quality, safety and environment considerations very seriously. As we grow and evolve, we continue to take measures to ensure that we provide our partners and community with a high standard of service.

ISO 13485 compliance

SUTUREX & RENODEX successfully passed the yearly follow-up audit confirming that our Quality Management System is in compliance with ISO 13485 standards and at the same time got certified for its Environmental Management System and on Health & Safety standards.

Quality Control

SUTUREX & RENODEX warranties strict quality control of each batch of suture needles. Each batch is identified and traceable from the raw materials, the production and to the shipment. Furthermore, the company delivers a certificate of conformity for each surgical needle batch. 

Inspection Control

Our quality lab has expertise in carrying on raw materials analysis, functional performance tests, such as tensile strength, ductility, penetration and corrosion tests.

SUTUREX & RENODEX also offers to its customers quality analysis for performing needle benchmarking.

Please ask us for surgical needle analysis.

Quality Certification

Description Document Link
ISO 13485:2016_SR Certificate
pdf (1.3 MB)
ISO 14001: 2015_SR Certificate
pdf (1.3 MB)
ISO 45001: 2018_SR Certificate
pdf (332.4 KB)