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Katsan provides training and certification support in the field of establishing, developing and managing a quality management system.
ISO EN ISO 13485 – Quality Management System (QMS) in Medical Devices
Katsan has ISO 13485 Medical Devices – Quality Management System since 2005. ISO 13485 is an internationally accepted standard with special requirements for medical devices. It is a quality management system that medical companies should establish within the scope of CE marking.
As Katsan, training of the requirements related to ISO 13485: 2016 Medical Devices – Quality Management System is provided, the first step is to establish a quality management system department within the company, and then ISO 13485 is applicable to all departments. Trainings are given about the reason why ISO 13485 system is necessary, what are its general requirements, other international standards that should be applied, documentation, efficiency of the system and sustainability of this system and studies are carried out with the company.
Technical File Preparation
The process of preparing technical files for medical device manufacturers is a detailed process that includes a long-term study. In order to prepare a technical file, it is very important that the responsible personnel have the standards, the Medical Device Regulations, the regulations issued and the requirements of the legislations published by the Ministry of Health of the Republic of Turkey..
Technical file documentation is a process that should be supported with evidence as much as possible. Product general safety and performance requirements, reliability,
Issues such as compliance with standards should be presented with objective evidence.
As Katsan, training is provided with the aim of providing guidance in providing evidence.
Pre-clinical Evaluation (Biocompatibility)
Pre-clinical tests, which is an important point that medical device regulation emphasizes in clinical evaluation studies. These are biocompatibility studies. Biocompatibility, by definition, is 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 a suitable host response in a particular application”.
Training and consultancy services are provided to medical devices on legislation regarding biocompatibility and clinical evaluation.