We are pleased to announce that the Skin-Elast-Hook has been successfully certified in accordance with EU Regulation 2017/745 (MDR). In addition, our quality management system has been audited and certified according to the international standard ISO 13485. In addition, our quality management system has been tested and certified in accordance with the international ISO 13485 standard.
The Skin-Elast-Hook is required for many intracranial procedures and supports safe access for the neurosurgeon.
The certifications underline our continuous commitment to the highest quality and safety standards in medical technology. The MDR certification confirms that the Skin-Elast-Hook meets all safety, performance and clinical benefit requirements as defined in the current EU regulation for medical devices. The ISO 13485 certification also proves that we operate an effective quality management system that is specifically designed for the development, production and distribution of medical products.
With these milestones, we not only create regulatory clarity, but also give our customers and partners the security of being able to rely on a tested and standard-compliant product.
