The Pharmacy weekly has published a review article about the seminar “Relevance of medical device conformity assessment through EC-certificates recognition during martial law”

30.05.2022

On May 19, a webinar was held on the topic: “Relevance of medical device conformity assessment through EC-certificates recognition during martial law”, the speakers of which were Viktoriia Shevchenko, Head of the Conformity Assessment Department of UNI-CERT LLC and Yana Sydiakina, Leading Specialist of the Assessment Division of UNI-CERT LLC.

The seminar showed the great relevance of carrying out conformity assessment of medical devices by recognizing certificates issued by notified bodies of the European Union for the period of martial law.

The Pharmacy Apteka published a review article about this seminar.
The full text in Ukrainian can be found here >>> https://www.apteka.ua/article/636039

Other news

26.08.2021

Regulatory requirements for medical devices in laboratory practice

PROGRAM Classification: medical device for IVD, RUO (research use only) and general laboratory equipment. Conformity assessment through self-declaration Conformity assessment performed by conformity assessment body: choosing the best procedure for your business application and documentation step-by-step description of the conformity assessment procedure through an audit of the manufacturing facilities special procedure for III class devices, […]

Read more
06.09.2021

Certification of medical device manufacturing by pharmaceutical companies

PROGRAM Nomenclature of medical devices in the “product portfolio” of pharmaceutical companies: medical devices supplied with a medicinal product medical devices for drug delivery products that are integral with the medicinal product products for IVD, RUO (research use only) and general laboratory equipment medical / cosmetic / hygienic purpose of products aids (accessories) Requirements of […]

Read more
25.06.2020

Features of the classification. Medical devices on the border of definitions.

PharmaTechExpo Journal №1-2, 2020. The text of the article is available only in Ukrainian

Read more