Providing clinical evidence under the MDR 2017/745: New challenges for manufacturers in medical device industry

Providing clinical evidence under the MDR 2017/745: New challenges for manufacturers in medical device industry

Providing necessary clinical evidence throughout the systems for Clinical Evaluation and Post-Market Surveillance in accordance with new MDR 2017/745 requirements imposes new challenges for manufacturers in medical device industry. Manufacturers should make clinical evaluation a continuous process t...

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Bibliographic Details
Main Authors: Ivanovska Elena, Tonić-Ribarska Jasmina, Lazova Jelena, Popstefanova Nada, Davcheva-Jovanoska Marija, Trajković-Jolevska Suzana
Format: Article
Language:srp
Published: Pharmaceutical Association of Serbia, Belgrade, Serbia 2019-01-01
Series:Arhiv za farmaciju
Subjects:
medical device regulation 2017/745 (mdr)
clinical evaluation
post-market surveillance (pms)
clinical investigation (ci)
post-market clinical follow-up (pmcf)
Online Access:https://scindeks-clanci.ceon.rs/data/pdf/0004-1963/2019/0004-19631901039I.pdf

Internet

https://scindeks-clanci.ceon.rs/data/pdf/0004-1963/2019/0004-19631901039I.pdf

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