Ukrainian Scientific Institute of Certification

Notified body representatives took part in the “Conformity Assessment A to Z: Import” workshop

04/04/2016

On 29-30 March, the workshop titled “Conformity Assessment A to Z: Import” was held at HUB 4.0 conference hall.

The participants included representatives from the Association of Medical Device Market Operators, leading experts from the Ministry of Health of Ukraine and the State img1Administration of Ukraine on Medicinal Products.

The workshop highlighted main and essential changes in the legislation applicable to medical devices.

Among the invitees were also specialists from the notified body Uni-CERT.

Tetiana Pazerska, the deputy director of quality and senior auditor, focused her presentation on specific features of conformity assessment for different types of medical devices, outlining the key points of the procedures for sterile devices, devices with a measuring function, Class III devices, procedure packs, and in vitro diagnostic devices.

One of the topics addressed was batch-by-batch conformity assessment.

img2A presentation on conformity assessment involving a comprehensive audit of the quality management system was given by Hanna Telpiakova, the senior auditor for Uni-CERT. The speaker described the on-site audit procedure and its main steps and indicated the most common nonconformities identified during stage 1 and stage 2 audits.

After the workshop, the participants were granted certificates of successful completion, attesting to their new knowledge, which can be put into practice.
 

Summing up the results of the workshop, the participants mentioned that the information.