Certification of medical device test, control and calibration service providers Tibbi Cihaz Test, Kontrol ve Kalibrasyon Hizmeti veren Kuruluşlarin Yetkilendirilmesi


SEZDİ M. , Sezdi N. I.

2017 Medical Technologies National Conference, TIPTEKNO 2017, Trabzon, Türkiye, 12 - 14 Ekim 2017, ss.1-6 identifier

  • Yayın Türü: Bildiri / Tam Metin Bildiri
  • Cilt numarası:
  • Doi Numarası: 10.1109/tiptekno.2017.8238119
  • Basıldığı Şehir: Trabzon
  • Basıldığı Ülke: Türkiye
  • Sayfa Sayıları: ss.1-6

Özet

© 2017 IEEE.This paper is written with the aim of presenting the studies about building standards-based and auditable measurement services for medical device test controls and calibrations in Turkey. In particular, the activities of biomedical metrology service providers about to train specialist personnel and to establish sectoral awareness in this field have been mentioned. Turkish Medicines and Medical Devices Agency issued a regulation on the subject and authorized the institutions that will provide training as the first stage. Thus, only authorized specialist staff will make the measurements and there will be the managers responsible for these measurements. In the service area, service will be fully assessed and inspected and metrological measurements, tests and controls will be provided in according to the standards.