Certification of the Importer / Distributor of medical devices

We provide of Quality Management System Certification of the Importer / Distributor of medical devices who:

a. provides information (including translation) supplied by the manufacturer, in accordance with Section 23 of Annex I MDR, relating to a device already placed on the market and of further information which is necessary in order to market the device in the relevant Member State;

b. makes changes to the outer packaging of a device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it.

Quality Management System Certification of the Importer / Distributor of medical devices is provided for the types of medical devices stated in the scope of our notification for MDR in NANDO database.

In case of interest in our services in the field of Quality Management System Certification of the Importer / Distributor of medical devices according to the MDR, please, send filled document „Application for Certification of Quality Management System of the Importer / Distributor“ on e-mail address info@3ec.sk. The general terms and conditions can be viewed at this link.

We provide performance of energy audit as required by law No. 321/2015 Coll. on energy efficiency and on amendments to certain laws.

Large companies with more than 250 employees with an annual turnover exceeding 50 million EUR and/or their annual balance sheet exceeds 43 million EUR are required to develop such energy audit until December 5th, 2015.

Large companies must perform an energy audit every four years or it can be elaborated either within the certified environmental management system as per ISO 14001:2015 or an energy management system as per ISO 50001:2018. Company with a certified management system is required to perform the energy audit only once during the period of certification.

Energy measurement is a systematic procedure to obtain adequate amount of information about the current state of technical equipment and buildings intended for use of energy and the identification and design of cost-effective energy savings opportunities.

The fact that our auditors are qualified to carry out energy measurements confirm the following certificates

O tom, že naši audítori sú spôsobilí vykonávať meranie energií svedčia nasledovné osvedčenia:

• Dr. Katarína Srdošová

• Dr. Mark Tomin

If you are interested in our offer, please, do not hesitate to contact us. We will be happy to guide you through our services.