QUALITY

Beyond Certification

SUTUREX & RENODEX is dedicated to the satisfaction of customers. The chain of quality is certified ISO 13485. All our surgical needles follow a strict quality control process ensuring the highest quality.

The ISO 13485 certification is very important accreditation for us, demonstrating our "Leading Choice" motto. Achieving the standard set by these global management systems shows our commitment to quality, the environment, safety and security in our Company. 

Put our employees’ safety and well-being at the top of our organization’s agenda with the near future implementation of the OHSAS 18001:2007 standard.

Sound occupational health and safety policies are essential for our employees, but they are also increasingly important for our customers and other stakeholders. Occupational Health and Safety Management systems certification to OHSAS 18001 is a strong sign of SUTUREX & RENODEX commitment to our employees’ health and safety.

All certifications are valid for three years and will undergo annual maintenance audits.

SUTUREX & RENODEX has also a quality laboratory for performing in-depth analysis of materials, finished products and new products.

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. 

Laboratory

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
IS0_13485_V2016_certificate
pdf (230.3 KB)