ISO 13485:2016. Switch to the new version of the standard.
On December 4-5, SGS conducted training "ISO13485:2016. Quality management systems for the production of medical devices. Switch to the new version of the standard." Our employees successfully passed exam and now are ready to inform clients on issues related to the new standard for medical devices.
TÜV SÜD expresses its support for the certification of medical devices in Ukraine
TÜV SÜD, the European notified body, affirms about its presence in Ukraine, as in a country that has the opportunity to conduct the procedure of recognition of certificates CE on medical devices, issued by TÜV SÜD, through the Ukrainian conformity assessment bodies. We are very pleased to realize that UNI-CERT, Ukrainian conformity assessment body...
A contract on recognition of the results of the assessment of conformity with Kiwa Cermet Italia S.p.a.
Dear colleagues! We are pleased to inform you that the European notified body Kiwa Cermet Italia S.p.a. has signed an arrangement for the recognition of conformity assessment results with the limited liability company UNI-CERT. Due to this collaboration, our clients can significantly reduce their time and financial expenses for certification of ...
5 years – The Association of Medical Operators for Medical Devices (AMOMD)!
On November 10, a festive event dedicated to the Birthday of AMOMD was held. We gladly congratulated our colleagues on the anniversary and wished further prosperity! Full photo-report here
Routine work on the server!
Dear colleagues! Scheduled maintenance work is on the server. Breaks can be observed in the work of the site and e-mail. We apologize for the inconvenience!
Results of seminar ‘Conformity assessment of the medical devices of national production. Conformity assessment of OBL-OEM production’
On November 7, 2017, training seminar on сonformity assessment of the medical devices of national production, creation of quality management systems in accordance with ISO 13485 and development of technical documentation was held. The organizers of the seminar are Association of market operators of medical devices (AMOMD), together with the members...
Regarding the market of medical devices in Ukraine as a result of 9 months 2017
According to the analytical system of market research "Pharmstandard"/ "PharmXplorer" of the company "Proxima Research", the market of medical devices in Ukraine continues to grow. At the same time, the rate of pharmacy sales growth of goods of Ukrainian producers is higher than foreign ones both in monetary and in-kind. More details on key indica...
On November 7, 2017, a seminar titled ‘Conformity assessment of the medical devices of national production. Conformity assessment of OBL-OEM production’ will take place
The organizers of the seminar are Association of market operators of medical devices (AMOMD), together with the members of the Association, company CRATIA and Ukrainian Scientific Institute of Certification. At this seminar, the speeches of our specialists are planned: Myroslava Boichuk, Head of Conformity Assessment Department: The requireme...
26th International Medical Exhibition ‘PUBLIC HEALTH 2017’ held on 3 – 5 October 2017
We thank everyone who met us at the stand during the exhibition and we hope that you have received answers to the most important questions that concern the conformity assessment of medical devices in Ukraine. We will be very pleased to meet you! You can contact us on the contact page
New Technical Regulation on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment
On 22 September 2017, the Technical Regulation on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment as approved by Resolution No. 139 of the Cabinet of Ministers of Ukraine dated 10 March 2017 came into force. This Technical Regulation has been developed on the basis of Directive 2011/65/EU of the ...