Innovation in bone healing and tissue repair
08 Feb 17
Kuros achieves ISO certification for surgical sealants

Schlieren (Zurich), Switzerland, February 8, 2017

Kuros achieves ISO certification for surgical sealants

Kuros Biosciences (SIX:KURN) announced today that the Company has been certified as European Normative (EN) ISO 13485:2012 compliant for the design, development, manufacturing and distribution of implantable polymeric sealants for surgical application. Receiving ISO certification is an important achievement towards obtaining a CE mark approval, for which Kuros submitted Neuroseal, a novel dural sealant device, in December 2016.

Kuros underwent a thorough evaluation process that included a quality management system review, a pre-audit, an initial assessment and a full audit in order to be certified as EN ISO 13485:2012 compliant. The certification was accredited by Dekra Certification BV and is valid until March 2019. EN ISO 13485:2012 certification is generally considered to be the first step toward obtaining a CE mark approval, the regulatory clearance recognized in the European Union and other countries that indicates that Kuros’ products consistently meet customer and regulatory requirements.

 

Didier Cowling, CEO of Kuros, commented: “We are very pleased to reach this important milestone for Kuros. This achievement recognizes that our policies, procedures and objectives are able to provide safe medical devices that comply with applicable statutory, regulatory and contractual requirements in the medical industry.” He continued: “The ISO certification is a mandatory prerequisite for our transition to commercial stage.”



Kuros Biosciences AG
Wagistrasse 25, 8952 Schlieren, Switzerland
Tel: +41 (0)44 200 56 00   Fax: +41 (0)44 200 56 01   Email: info@kuros.ch

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    Neuroseal (KUR-023)

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Article
08 Feb 17
Kuros achieves ISO certification for surgical sealants

Schlieren (Zurich), Switzerland, February 8, 2017

Kuros achieves ISO certification for surgical sealants

Kuros Biosciences (SIX:KURN) announced today that the Company has been certified as European Normative (EN) ISO 13485:2012 compliant for the design, development, manufacturing and distribution of implantable polymeric sealants for surgical application. Receiving ISO certification is an important achievement towards obtaining a CE mark approval, for which Kuros submitted Neuroseal, a novel dural sealant device, in December 2016.

Kuros underwent a thorough evaluation process that included a quality management system review, a pre-audit, an initial assessment and a full audit in order to be certified as EN ISO 13485:2012 compliant. The certification was accredited by Dekra Certification BV and is valid until March 2019. EN ISO 13485:2012 certification is generally considered to be the first step toward obtaining a CE mark approval, the regulatory clearance recognized in the European Union and other countries that indicates that Kuros’ products consistently meet customer and regulatory requirements.

 

Didier Cowling, CEO of Kuros, commented: “We are very pleased to reach this important milestone for Kuros. This achievement recognizes that our policies, procedures and objectives are able to provide safe medical devices that comply with applicable statutory, regulatory and contractual requirements in the medical industry.” He continued: “The ISO certification is a mandatory prerequisite for our transition to commercial stage.”