June 19, 2011 — Electromedical Technologies, announced that the company has been awarded ISO 13485:2003, CE approval and CAN/CSA ISO Certifications.
Electromedical joins the ranks of top internationally renowned medical device manufacturers who have obtained ISO 13485:2003 quality system certificates. ISO 13485:2003 is a specific international quality management system standard that requires an organization to demonstrate its ability to consistently provide products and services at the highest level of quality.
The ISO 13485:2003 certificate is a mandatory requirement to demonstrate compliance with appropriate medical device regulatory and statutory requirements for CE-marking in the European Union and CAN/CSA for Canadian approval.
The company’s CEO, Matthew Wolfson, stated “Electromedical Technologies has always been committed to effectiveness of our products as well as patient safety and customer satisfaction. We stand behind all of our products and services provided to our customers. By demonstrating to the International Standards Organization our ability to meet these Quality Standards, especially ISO 13485:2003, means that Electromedical Technologies has achieved the highest level of compliance possible for a world-class manufacturing company.”
In addition to the ISO certification, Electromedical Technologies has also received CE Mark approval and the Canadian CAN/CAS (similar to the FDA in the U.S.). For medical devices, the CE mark and Canadian CAN/CAS is awarded only to those companies that both satisfy the rigorous standards of ISO 13485:2003 and comply with the European Union’s Medical Device Directive (MDD).”
Wolfson stated, “These approvals are Huge, this is the culmination of more than two years hard work by all of Electromedical Technologies’ employees. We are proud of the tremendous efforts made by our TEAM in bringing this process to a successful conclusion. The ISO certification, Canadian CAN/CAS and CE approvals open the international doors for our distributors to expand and build their Wellness Pro businesses in many different countries around the world with a license in hand.”
Source: Electromedical Technologies, www.electromedtech.com