Page 220 - Mart 2019

Haber

TıbbiCE Conducted More Than 300 Medical Device Certification
Processes of Over 100 Medical Device Manufacturers in 8 Years

TıbbiCE Consultancy Training and Validati- would like to remind our manufacturers that a CE
on Services, which provides medical device cer- certificate to be taken in 2019 will be valid for 5
tification and consultancy services, shares the years and to experience this process not by living
knowledge and experience gained from more it but by observing and hearing it.”
than 300 medical device certification processes “TıbbiCE Consultancy Training and Valida-
of over 100 medical device manufacturers in 8 tion Services offers consulting, training and va-
years. TıbbiCE aims to complete the certificati- lidation services for medical device manufactu-
on processes of the companies in a professional rers both in Turkey and abroad in ISO 13485 and
manner and complete them in the optimum time. CE Certification (93/42 / EEC) processes. 47%
Answering questions of Sağlık Dergisi, General of our 2018 endorsements were consultancy and
Manager Gökhan Yalçın said that the most im- training activities that we perform abroad, and
portant feature that distinguishes them from ot- TıbbiCE has broke a new ground in Turkey. Tıb-
her consultancy companies is to offer Quality biCE Consultancy Training and Validation Servi-
Management System and Product Certification ces, formed with 10 personnel which are expert
Consultancy to Medical Device Manufacturers in their field containing biologists, biomedical,
without breaking the energy of the whole staff. machine, metallurgical and medical engineers, is
Yalçın also stated that the first transition years a company that has Turkey’s largest expert squad
of the new European Medical Device Regulation and runs only Medical Device Certification Con-
(MDR) would be relatively difficult and said, “I sultancy activities.”

218 Mart 2019