New MDR and ISO 13485 requirements for a distributor of a foreign manufacturer

25.08.2023

The Ukrainian Scientific Institute of Certification invites you to take part in the 12th Ukrainian Forum of Medical Devices Market Operators®. In this difficult period for our country, more than ever, it is necessary to be aware of the latest key changes in the functioning of the medical device market. Therefore, the Ukrainian Forum of Medical Devices Market Operators provides manufacturers, suppliers, distributors, importers of medical devices with a platform to address all pressing issues, discussions, recommendations and exchange of valuable business experience during martial law.

At this event, Nikolay Matlaev, Lead auditor of the Conformity assessment department of the Ukrainian Scientific Institute of Certification, will make a presentation on the topic “New MDR and ISO 13485 requirements for a distributor of a foreign manufacturer”.

Preliminary program of the Forum

Forum website: https://bit.ly/43rYGd2

Registration of participation at the link: https://bit.ly/43zO4Zs

Contacts of the forum organizers:

We will be glad to see you among the participants of the event!

Other news

17.05.2021

UNI-CERT extended the field of activity of its Testing Laboratory

Once again, the Ukrainian Scientific Institute of Certification has extended the accreditation scope of its Testing Laboratory UNI-CERT LLC, and this time by 23 standards and 127 test indicators in the field of Personal Protective Equipment (PPE). According to the accreditation certificate No. 201394 and number of additions to the accreditation scope, the Testing Laboratory […]

Read more
08.06.2022

UNI-CERT received accreditation for DSTU EN ISO 22716:2015

The Ukrainian Scientific Institute of Certification became the FIRST conformity assessment body in Ukraine, accredited to carry out activities in a new line of business: DSTU EN ISO 22716:2015 Cosmetics. Good Manufacturing Practice (GMP). Guidelines on Good Manufacturing Practices (EN ISO 22716:2007, IDT) and EN ISO 22716:2007 Cosmetics – Good Manufacturing Practices (GMP) – Guidelines […]

Read more
31.07.2023

How to implement a quality management system according to DSTU EN ISO 13485:2018 in the central sterilization department

Management of the healthcare institution No. 7 July 2023 The text of the article is available only in Ukrainian

Read more