Conformed Eğitim ve Danışmanlık Hizmetleri Ltd. Şti.

Who is CONFORMED?

CONFORMED Training and Consulting Services LTD. provides training and consulting services for ISO 13485 and CE certification processes required for medical device manufacturers.

CONFORMED has provided services in over 70 product ranges, some of which are mentioned in the "Our References" section. With the experience it has gained, it has adopted the principle of being alongside medical device manufacturers not only during the certification process but also after its completion.

Our Scope of Services

We provide services to medical device manufacturers in both establishing Quality Management Systems in accordance with the ISO 13485 Standard and preparing Technical Files in accordance with the 93/42/EC Medical Devices Directive.

CONFORMED has also succeeded in supporting manufacturers in the certification processes by coordinating with all Notified Bodies and Test Laboratories selected according to the manufacturers' wishes.

With our service content, we aim to ensure that manufacturers are prepared for unannounced field inspections that may be carried out directly by the Ministry of Health.

Why Do We Only Provide Services in the Field of Medical Devices?

First and foremost, the fact that the subject is the healthcare sector makes product quality indispensable.

In line with our commitment to providing professional answers and solutions to constantly evolving expectations, we have adopted as our fundamental service philosophy the adaptation of our products and processes to Quality Management Systems and Technical Documents by complying with updated standards/regulations/guidelines and incorporating new approaches.

The constantly changing and increasing expectations necessitate that Technical File studies, which verify product safety and performance, become a living cycle linked to the Quality Management System.

We understand how challenging this situation is for medical device manufacturers.

With this awareness, CONFORMED has adopted the principle of adapting to evolving/changing standards/regulations/guidelines primarily within its own organization and being by your side with a continuous improvement approach.

For these reasons, we have decided to focus our knowledge, expertise, and experience on a single area in order to provide you, our customers, with better service.

From its inception, CONFORMED has been recognized in the consulting sector for its emphasis on quality, continuous improvement, and innovative approach, and it has never deviated from these principles.

Our main goal is to be best in class in terms of quality, service, our supply sources, and our relationships with manufacturers, and to always maintain this image we have.

Ihsan KARCIOGLU