Brown Deer, WI (February 11, 2009)– Alpha Source / Access Battery’s Class 2 Battery Packs are now licensed with Health Canada. Licensing from Health Canada authorizes Alpha Source and Access Battery to export Class 2 battery packs used in life support applications such as syringe pumps, ventilators, defibrillators, and infusion pumps for use and sale within the Canadian market.
Health Canada as compared with the United States Federal Drug Administration (FDA) helps protect the Canadian public by researching, assessing and collaborating in the management of the health risks and safety hazards associated with Canadian consumer products. As a part of its function, Health Canada implements a licensing process that ensures Canadian institutions that receive medical devices are receiving products manufactured to the highest quality standards.
The Alpha Source / Access Battery licensing process took approximately six months and included registering their ISO 13485:2003 Quality System, which was achieved in October 2006.
In an ongoing effort to ensure the highest quality in manufacturing and distribution, Alpha Source / Access Battery hold internal audits to confirm compliance with ISO 13485:2003 and Current Good Manufacturing Practices (CGMPs) as required by the FDA. In 2008 Alpha Source implemented Pilgrim Software SMART Solve (SAAS-based) a software tool used to manage its quality management system.
“By becoming ISO13485:2003 Certified and maintaining our compliance with Current Good Manufacturing Practices (CGMPs), Alpha Source / Access Battery is positing itself to be a market leader by putting quality regulatory and customer needs at the forefront of all distribution and manufacturing practices,” says Alpha Source / Access Battery Quality and Regulatory Affairs Manager, George Uriniuk.
Alpha Source, Inc. is a Women Business Enterprise (WBE) founded in 1986 and is a global distributor of new and replacement medical devices and accessories and battery pack manufacturer. In 2005, Alpha Source President, Norine Carlson-Weber, purchased Access Battery in order to expand Alpha Source’s medical and communications battery product line.