KAUL MEDIZINTECHNIK GMBH has successfully achieved UAF-accredited 13485:2016 certification. It shows the organisation’s commitment to the highest standards of quality, safety, and regulatory compliance in the medical device sector.
ISO 13485:2016 is the globally recognized benchmark for quality management system specifically designed for organizations involved in the medical device lifecycle, where precision is non-negotiable and patient safety is paramount.
Achieving ISO 13485:2016 demonstrates that KAUL MEDIZINTECHNIK GMBH has established a robust, risk-based quality management framework that governs every critical stage from design and development to manufacturing, storage, and supply.
The scope of the management system includes Design, Development, Manufacturing and Storage Supply of Sterile & Non-Sterile Bone Plates, Bone Screws, Bone Nails, Wire, Pins & Washers, Spinal Implants, Cranial & Maxillofacial Implants, Arthroscopy Implants, External Fixator, Orthopaedic Surgical Instruments For Trauma, Spinal, External Fixators.
Medical device manufacturing operates under intense regulatory scrutiny. ISO 13485:2016 ensures that quality is built into the system.
The standard emphasizes risk management, product traceability, process validation, and strict control over both sterile and non-sterile production environments. Â KAUL MEDIZINTECHNIK GMBH can ensure stronger regulatory alignment and greater confidence among surgeons, hospitals, and global distribution partners.
SIS Certifications is recognized for its transparent, impartial, and rigorous audit methodology. During the certification audit, the audit team observed KAUL MEDIZINTECHNIK GMBH’s strong process orientation, comprehensive documentation practices, and clear leadership commitment to quality and regulatory compliance.
Achieving ISO 13485:2016 certification with SIS Certifications reflects KAUL MEDIZINTECHNIK GMBH’s focused approach to operational excellence, patient safety, and long-term sustainability.
