The entire process, from design through to dispatch, takes place in-house. This allows us to maintain full control over every stage of the process and deliver a sterile, ready-to-use product that meets the highest safety and quality standards. By continuously improving, carefully managing risks, and working in accordance with strict regulations, we ensure that every implant is reliable and consistent, both in quality and in application.
The European Medical Device Regulation (MDR) sets stringent requirements for the development, production and use of medical devices. Our certification in accordance with (EU) MDR 2017/745 confirms that our processes and products comply with this European legislation.
This means, among other things, that we work with a validated and certified quality management system, comprehensive documentation, and strict control of risks and performance. In this way, we can demonstrably deliver what is required for safe and reliable use in practice. Would you like to know more or receive documentation? Please feel free to contact us.
ISO 13485:2016 is the international standard for quality management in medical technology. This certification confirms that our processes are structurally organised around quality, safety and continuous improvement.
From production and validation to release and delivery: every step is safeguarded within a controlled and documented process. This enables us to deliver consistently and comply with the requirements of both regulation and practice.
