Who is CONFORMED?

CONFORMED Eğitim Ve Danışmanlık Hizmetleri LTD. ŞTİ. provides training and consultancy services for Medical Device Manufacturers in the necessary ISO 13485 and CE Certification processes.

CONFORMED has served in over 250 product ranges, some of which are mentioned in the “References” section. With its accumulated experience, it has made it a principle to stand by Medical Device Manufacturers not only during the certification process but also after the completion of the process.

Our Service Scope

We provide services to Medical Device Manufacturers in the establishment of Quality Management Systems according to the ISO 13485 Standard, as well as in the preparation of Technical Files in line with the 2017/745/EU Medical Device Regulation (MDR) and Medical Device Directives.

CONFORMED has also successfully assisted Manufacturers in coordinating with all Notified Bodies and Testing Laboratories, as selected according to the Manufacturer’s wishes, during the Certification processes.

Our service content aims to ensure that manufacturers are prepared for unannounced field inspections that can be carried out by the Ministry of Health.

Why Do We Only Provide Services in the Medical Devices Sector?

Above all, since the subject is healthcare, product quality is paramount.

In order to respond professionally to constantly changing new expectations and produce solutions; we adopt the approach of ensuring compliance with updated standards/regulations/guidelines and adapting the Quality Management System and Technical Files, which include products and processes, to new approaches as our core service philosophy.

The continuous change and increase in expectations require that the Technical File work, which validates the product’s safety and performance, becomes a living cycle connected to the Quality Management System.

We are aware of how problematic this situation can be for Medical Device Manufacturers.

With this awareness, CONFORMED has made it its principle to first comply with the evolving/changed standards/regulations/guidelines within its own structure and continuously develop while standing by you with a continuous improvement approach.

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

Since its establishment, CONFORMED has been recognized in the consultancy sector for its commitment to quality, continuous development, and innovative approach, and it has never compromised on these principles.

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

General Manager

İhsan KARCIOĞLU