by
Barbara Kram, Editor | April 16, 2010
Epoka Medic Mission has received the DGM (Danish Medical Devices Certification), an ISO quality system certificate from Denmark. The scope of the ISO 13485 certification is: Repair and refurbishment of used medical imaging equipment and storage thereof. In their refurbishment center they currently refurbish CT and ultrasound scanners.
This designation (DS/EN ISO 13485:2003 + AC:2009) from DGM is the imprimatur of a body focused on medical devices and so represents a significant quality indicator. DGM is an independent business unit within DS Certifying A/S notified by the Ministry of Welfare for the approval of medical devices and in vitro diagnostic medical devices (IVD).

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Epoka told DOTmed news that they went for the ISO 13485 (medical devices, quality management systems, requirements for regulatory purposes) instead of the more general ISO 9001 (quality management systems, requirements) to show that they comply to the specific requirements set for medical devices.
ISO has 159 member states worldwide and the ISO standards and certifications are honored worldwide.
"The ISO certification is a big acknowledgment of the fantastic team we have at Epoka Medic Mission, and also a strong security for all the customers that are buying equipment from our company, contributing to their own and Epoka Medic Mission's success," said
Lars Braun Nielsen, CEO. "To achieve an ISO certification requires a lot of hard work and effort, but at the same time we have achieved a lot by focusing all our energy in making this happen; and we are happy to share this with our colleagues in order to increase the overall standard in our industry, which will be beneficiary to all."
In addition to the ISO 13485 certification they have the ISPM 15 certification for complying with the regulation for wood packaging material in international trade in their packaging department. International Standards for Phytosanitary Measures (ISPM) are issued by the International Plant Protection Convention.
Epoka Medic Mission is a worldwide reseller of imaging equipment. Their company has a strong reputation in the medical world for providing a cost effective, highly reliable and professional service. Epoka does business in more than 130 countries worldwide. Their strongest focus is on business relations, trust, reliability and flexibility. They have 25 employees in Denmark and more than 70 technicians worldwide. Their technical staff handles refurbishing and testing in technical facilities in Pandrup where a 3,000-square-meter warehouse stocks all types of equipment.