13485 Quality Management System (QMS) in Medical Devices
Katsan has had ISO 13485 Medical Devices – Quality Management System since 2005. ISO 13485 is an internationally recognized standard that contains specific requirements for medical devices. It is a quality management system that companies must establish within the scope of CE marking in medical devices.
As Katsan, we provide training on the requirements regarding ISO 13485:2016 Medical Devices – Quality Management System, and in the first step, we create a quality management system department within the company, and then ensure that ISO 13485 can be applied by all departments. Training is given and work is carried out with the company on why the ISO 13485 system is necessary, what its general requirements are, other international standards that need to be applied together, documentation, the efficiency of the system and the sustainability of this system.
Technical File Preparation
The technical file preparation process for medical device manufacturers is a detailed process that involves long-term work. To prepare the technical file, the responsible personnel must comply with the standards, Medical Device Regulation, published regulations and Turkish Republic. It is of great importance to have knowledge of the requirements of the legislation published by the Ministry of Health.
Technical file documentation is a process that should be supported by as much evidence as possible. Product general safety and performance requirements, reliability,
Issues such as compliance with standards must be presented with objective evidence.
As Katsan, training is provided with the aim of providing guidance in providing evidence.
Preliminary Clinical Evaluation (Biocompatibility Studies)
Pre-clinical tests are an important point that medical device regulation also emphasizes in clinical evaluation studies. These are biocompatibility studies. Biocompatibility is, by definition, a measure of how compatible a device is with a biological system. The ISO 10993 standard defines biocompatibility as “the ability of a medical device or material to perform with an appropriate host response in a particular application.”
Training and consultancy services are provided on biocompatibility and clinical evaluation of medical devices, legislation.