HemCon Receives CE Marking for Unique Hemorrhage Control Bandage; Certification Will Allow Expanded Presence into International Markets.PORTLAND, Ore. -- HemCon Inc. has received the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community CE marking for its unique hemorrhage control bandage. Since the U.S. Army began issuing the bandage to all of its front line troops, international demand for the bandage has been strong. With receipt of this certification, HemCon will be positioned to begin distributing into countries requiring the CE marking, including: Great Britain Great Britain, officially United Kingdom of Great Britain and Northern Ireland, constitutional monarchy (2005 est. pop. 60,441,000), 94,226 sq mi (244,044 sq km), on the British Isles, off W Europe. The country is often referred to simply as Britain. , Germany and the rest of the EU. "The U.S. Military has proven that the HemCon bandage is a safe and highly effective product in controlling severe battlefield hemorrhage. It has been documented to have saved dozens of soldiers' lives without causing any adverse effects." stated HemCon, Inc. President and Chief Executive Officer John W. Morgan John W. Morgan, BSc, LLB, MBA (born May 7, 1964), is a Canadian Lawyer, politician, and businessman. He is the current mayor of the Cape Breton Regional Municipality in Nova Scotia, Canada. . "The CE mark will now allow us to increase our market presence to other key nations." In addition to the CE marking, HemCon has also earned ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 13485:2003 certification, the international quality management standard for designers and manufacturers of medical devices. This standard requires companies to have a quality management system (QMS (1) (Minolta-QMS, Inc., Mobile, AL) A manufacturer of laser printers founded in 1977 by Jim Busby. Initially involved with controllers for printing bar codes and labels, it entered the laser printer business in the mid-1980s and set numerous records. ) that embraces all activities of the company, including: staff training, customer service, order processing, design and development, purchasing and product delivery. As part of this certification, HemCon was also audited for compliance with CMDR Cmdr Commander (Canadian Medical Device Regulations) and the European MDD MDD Major depressive disorder, see there (Medical Device Directive). "This ISO certification demonstrates the commitment to quality and customer satisfaction that has been a cornerstone of HemCon since its inception," said HemCon, Inc. President and Chief Executive Officer John W. Morgan. "Receiving this certification is a credit to the quality work of the people who design, manufacture and market HemCon products." About HemCon, Inc. HemCon, Inc., founded in 2001, develops, manufactures, and markets innovative dressings and wound care technologies to control bleeding and infection resulting from trauma or surgery. The HemCon(R) Bandage is designed for use by first responders in military, emergency medical and other out-of-hospital environments where the rapid control of bleeding is of critical importance. HemCon's manufacturing and office headquarters is located in Portland, Oregon, USA. |
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