ISO 13485 Quality Management System for Medical Devices
(EU) 2017/745 Medical Device Regulation
Quality System Installation / Control and Improvement
Esra Tatli Training and Consultancy provides support for the establishment of a quality management system in accordance with ISO 13485 standard or the determination of the necessary improvements and the compliance of an existing quality system with its academic equipment and knowledge gained from the sector experience. Within the framework of system installation, firstly the physical structure and functioning of the service provider is examined, and detailed interviews are conducted with customers and expectations and limitations are discussed. Subsequently, necessary training are planned, implemented, a documentation framework is established and an efficient quality system is created following periodic meetings and reviews performed with the customer.
Customers of Esra Tatlı Training and Consultancy are able to carry out third party audits without the need of their consultants.
Preparation for Medical Device CE Certification Process
We offer the necessary support for our customers to meet the requirements of the relevant legislation for the products they want to be certified. Depending on the demands of our customers, we can limit our service process to training or we can carry out filing and necessary applications. We conduct interviews to determine the product class and the conformity assessment procedure, examine the products in their areas of use and obtain the necessary information. We ensure that design and technical dossiers are created according to product class, and that compelling processes such as clinical evaluation and after-sales surveillance are created within the framework of risk management in accordance with ISO 14971 standard.
- ISO 13485 QMS Case Studies,
- CE Certification of Medical Devices;
- MDD and MDR,
- Documentation and File Preparation,
- ISO 14971 Risk Management Standard
topics such as; but not limited to. Depending on the customer needs, programs can be provided with a detailed and / or training plan that covers more than one subject.
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