Top quality without compromises. The quality management system covers all areas of activity, is certified according to ISO 9001:2015 and is audited annually by international body and our clients.
Since 2006, we have been trusted by the most complex projects and we have met expectations. Today we cooperate with more than 1000 international manufacturers of healthcare products.
Our team consists of over 130 professionals with excellent knowledge of national and international legislation. We love our work and always try to do more than is expected.
Our work is related to health and life. We are aware of our responsibility, strictly following national and international legislation, confidentiality and business ethics principles.
This digest contains the most critical updates of the first half of 2021 related to regulatory, safety, and quality affairs for me...
9 September 2021
In this digest you will find the most important news on registration, safety and quality management of medicinal products in the C...
25 September 2020
EU recognition of certificates, remote audits and approvals in the interest of health: how certification of medical devices goes i...
22 May 2020
About three years ago the first Agreement on recognition of conformity assessment results was signed by notified body TÜV SÜD. Thi...
8 October 2019
Joint seminar related to the influence of new language policy on the medical market operators has been hosted by Cratia and Associ...
12 July 2019
1. All medical devices that include radio equipment (Wi-Fi, Bluetooth, GPRS and other radio communication modules) must comply wit...
8 February 2019
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