Quality management system at enterprises importing and selling medical devices. General information.

Other news

10.12.2019

Recognition of EU certificates for medical devices in Ukraine. Simplification, shortening of term and reduction of costs for conformity assessment with the requirements of Technical Regulations.

Since the Technical Regulations entered into force, discussions on the possibility of simplifying conformity assessment procedures, especially for medical devices of high-risk classes have been underway. Recently, we have had positive and relevant news regarding the recognition procedures in Ukraine for certificates of conformity issued by some notified bodies, accredited in the EU. To put […]

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

13.03.2023

Requirements and rules for placing medical devices on the market, including in vitro, for legal implementation

PROGRAM The importance of quality control of medical products for business Classification of medical products SI units Marking. Meaning of symbols. New symbols of 2022. Instructions for medical products Accompanying documents. Certificates of conformity. Declaration of conformity. Methods of checking the validity of certificates