KAUL MEDIZINTECHNIK GMBH has completed the Surveillance-02 audit and received a favourable recommendation for the continuation of its UAF-accredited ISO 13485:2016 Certification for Medical Devices – Quality Management System (MD–QMS).
The scope of the certification includes the 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, Orthopedic Surgical Instruments For Trauma, Spinal, External Fixators.
KAUL MEDIZINTECHNIK GMBH can also apply for ISO 14001:2015 Certification for Environmental Management System (EMS) to adopt eco-friendly manufacturing practices and achieve sustainable growth.
What is ISO 13485:2016 Certification?
ISO 13485 is a globally accepted Quality Management System (QMS) standard specifically designed for organizations involved in the design, manufacture, installation, servicing, and distribution of medical devices. Recognized as a key quality benchmark in the medical device sector, the certification strengthens an organization’s credibility with regulators, stakeholders, and customers, while enabling faster and smoother market access for medical products.
Benefits of the ISO 13485 standard for KAUL MEDIZINTECHNIK GMBH
KAUL MEDIZINTECHNIK GMBH can obtain the following benefits by implementing ISO 13485:2016 certification. These are as follows:
- ISO 13485 aligns closely with global regulatory requirements, helping KAUL MEDIZINTECHNIK GMBH meet the stringent medical device standards of international markets.
- The ISO 13485 standard requires KAUL MEDIZINTECHNIK GMBH to adhere to legal and regulatory quality standards to avoid legal complications. As a result, it reduces the risk of product defects, ensuring that medical devices are safe and effective for patient use.
- ISO 13485 helps KAUL MEDIZINTECHNIK GMBH streamline quality management processes. Hence, it leads to better documentation, risk management, and operational consistency.
Conclusion
KAUL MEDIZINTECHNIK GMBH has received ISO 13485:2016 certification, demonstrating its commitment to quality and regulatory compliance in the medical device industry. Moreover, this certification not only strengthens the organization’s position in the global market but also ensures the safety and effectiveness of its products.
