All KYERON implants carry the CE-mark and a certificate of quality (Class III). It's our responsibility to offer safe and effective biomaterials. Therefore our products are manufactured in accordance with ISO13485:2016 and under a Full Quality Assurance System according Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4.


KYERON operates an approved quality management system which complies with the requirements of EN ISO13485:2016 certified for the design, manufacture, and sales of sterile ceramic bone graft substitutes, sterile resorbable collagen and biopolymers. This ISO13485 certificate was awarded by our notified body.

General Requirements

KYERON has established, documented, implemented and maintained a quality management system and shall continually improve its effectiveness in accordance with ISO13485:2016.


1) Identified the processes needed for the quality management system and their application throughout KYERON
2) Determined the sequence and interaction of these processes
3) Determined criteria and methods needed to ensure that both operatiion and control of these processes are effective
4) Ensured the availability of resources and information necesarry to support the operation of these operations
5) Monitored, measured and analyzed these processes
6) Implemented actions necessary to achieve planned results and continual improvement of these processes

These processes are managed by KYERON in accordance with the requirements of the ISO13485:2016.

Management Commitment
The management of KYERON provides evidence of its commitment to the development and implementation of the quality management system described in the quality assurance manual and continually improving its effectiveness.

Quality Policy
The management of KYERON ensures that the quality policy:

1) Is appropriate to the purpose and delivery of medical products to specified requirements including after sales services
2) Includes a commitment to comply with the requirements and continually improve the effectiveness of the quality management system
3) Provides a framework tor establishing and reviewing quality objectives
4) Reviewing for continuing suitability


The quality policy is part of the quality assurance manual and signed by the director of KYERON.

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