Quality

 

Quality inspection

Quality inspection/testing is conducted throughout the entire technical flow to show together with documented evidence that the medical device was manufactured in accordance with the technical specification and meets all of the acceptance criteria/specifications outlined in its specifications. The inspections and tests are conducted on a vast number of samples determined by applying statistical techniques.

Multistep inspection/testing

Raw materials

All purchased raw materials which influence the manufacturing of, or is intended for use as part of, deliverable products is subject to inspection and/or testing before usage.

In technological-flow

In-process inspection/testing is conducted to ensure that the product/process conforms to specified requirements.

Final product

In order to establish the conformity of each batch, final inspection/testing is utilized. The inspection and test status of all materials is clearly visible throughout all stages of production. Only materials that have passed the required inspections/tests are released for further processing or shipment.

News

What our clients say

News

  • Biosintex Certificates

    As part of its commitment to manufacture high quality, reliable and innovative medical devices, Biosintex is pleased to announce the granting of new certificates for its quality management system and ...

What our clients say

  • I appreciate the quality of BIOSINTEX suture especially it’s resistance to knotting, the exceptional quality of the needles, the materials used, ensuring that the products meets to our expectations.

    Dr. Schaas Carmina Mihaela , Head of OR Department, Clinical Obstetrics and Gynecology Hospital Cuza Voda
  • We appreciate BIOSINTEX sutures for their quality. We found the sutures safe and effective, with superior handling characteristics, providing a good knot security and minimal tissue reaction. Our clients are pleasantly surprised especially by the non-absorbable range, such as Biopro, Bioster, Biosilk. However, BIOSINTEX has a complete portfolio – absorbable and non-absorbable sutures - which allows us to further meet all the needs of our healthcare professionals. At the same time, we want to thank and appreciate BIOSINTEX team, who have shown maximum professionalism and reliability during our collaboration.

    Bercha Valeriy, Director,
    Medical Service Ukraine
  • The standards of Romanian Students' Society of Surgery’s workshops are maintained at a high level, thanks to the BIOSINTEX sutures, which help us meet the expectations and demands of our teachers, from whom we have received rave reviews regarding our partnership with BIOSINTEX. The quality of BIOSINTEX sutures leads to a high level of professionalism, wich is necessary for the future doctors. We are grateful to BIOSINTEX team for their professionalism, compassion and interest in supporting the continuous medical education.

    Romanian Students'
    Society of Surgery
  • When in the middle of surgery and all manoeuvres are vital for the pacient, the assurance of quality materials is a must in order to sustain a correct surgical procedure. With BIOSINTEX, we have that assurance.

    Dr. Florin Săvulescu, Col, MD, PhD, Head of Department of Surgery, Central Military University Emergency Hospital ”Dr. Carol Davila”
  • We are satisfied of our relationship with BIOSINTEX, based on good quality of device, services and delivery time.

    Benedetta Moroni,
    Quality Assurance, Fazzini SRL, Italy
  • BIOSINTEX products are of very high quality, on a par if not better than many other established brands. We have no hesitation in recommending them in every way possible. They make us look good with our clients, and this means increased business for us in our very difficult market. A client for BIOSINTEX is not just a client, but a friend.

    Mario Debono,
    Director Alphafarma
  • It is still talked about the poor quality products that are delivered to romanian hospitals. We had the pleasure to disagree to this! As a doctor who has worked several years in western Europe, I can confirm that the sutures, meshes and other disposables produced by BIOSINTEX are of the same quality as equivalent products used in the west. Colleagues of mine have also agreed to this.

    Conf. Dr. Vărcus Flore, Coordinator of OR Department, County Emergency Clinical Hospital Timisoara
  • I would like to express my gratitude to BIOSINTEX, for the great service offered in terms of prompt deliveries of their products. I am very pleased with the quality of BIOSINTEX’s products, and especially with the price/quality ratio. There are many products on the market, but BIOSINTEX's products are distinguished by a very good quality at a decent price, which makes me choose them every time I have this opportunity.

    Dr. Seicean Radu, Primary Surgeon, Clinical Emergency Hospital Cluj-Napoca

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