The most basic expectation of the companies that set up and manage the ISO 13485 Medical Devices - Quality Management System is to open the doors of the medical sector and expand the customer portfolios. Because if they get the certificate of this system, it will be faster and easier to reach markets around the world. In addition, the cost of the system will decrease and the efficiency will be increased by the system is also additional earnings for the companies.
ISO 13485 Companies with Quality Management System Certificate for Medical Device Manufacturers will have brought the requirements of legal regulations on the one hand, and they will gain other gains in terms of increasing the customer satisfaction both in order to overcome legal audits easily.
Thanks to ISO 13485 standards, companies have established an international production system at all stages of production of medical devices, including R & D activities, manufacturing activities and quality.
It should also be noted that ISO 13485 standards are an effective way for manufacturers or suppliers who wish to place CE marking on their products.
In order to implement the TS EN ISO 13485 Medical Devices - Quality Management System standards and ensure the continuity of the application, TURCERT certification bodyIn addition to certification studies, it also provides consultancy and training services. The training subjects of the TURCERT certification body regarding the TS EN ISO 13485 Medical Devices - Quality Management System are as follows:
- TS EN ISO 13485 Medical Devices - Quality Management System Training
- TS EN ISO 13485 Medical Devices - Documentation Training
From these trainings, TS EN ISO 13485 Medical Devices - Quality Management System TrainingTo inform the participants about the design, development, production, establishment of the medical devices and the frame of the services to be provided.
The main topics of ISO 13485 Medical Devices - Quality Management System Training given by the TURCERT certification body are:
- TSE certification procedure
- Basic concepts about quality
- Organizational structure in quality management systems
- Introduction of TS EN ISO 13485 standard
- Interpretation of TS EN ISO 13485 standard clauses
- Case studies
It is mandatory to continue these trainings in order to obtain the expected benefit from the ISO 13485 Medical Devices - Quality Management System Training, which is a three-day training. At the end of the training, the certificate of achievement is given to the successful participants and the participant certificate is given to the others.
The instructors of the TURCERT certification body are also experienced and specialized in this area and many examples are shown during these trainings. This is also possible if the company requires training to be provided in their work environment.
If more information is required on ISO 13485 Medical Devices - Quality Management System Training or if it is requested to provide this training, experienced employees of TURCERT certification body will be with you immediately.