nieuws!!!
American Scientific Resources Becomes Approved Manufacturer
American Scientific Resources Becomes Approved Manufacturer
Nov. 23, 2010 (PR Newswire) --
WESTON, Fla., Nov. 23, 2010 /PRNewswire/ -- American Scientific Resources, Inc. (the "Company" or "ASR") (Pink Sheets: ASFX) announces today that the Company is officially an approved manufacturer of medical devices under the International Organization for Standardization (ISO), the world's largest developer and publisher of international business standards.
ASR also recently became a FDA approved manufacturer of various medical devices operating under the ISO 13485 Directive of Quality Systems Manual and Good Manufacturing Practices.
Within the past week, the Company went through an ISO inspection conducted by world renowned TUV SUD. The one-week highly intensive process included implementing a complete traceability and management accountability function in all aspects for a medical device manufacturer and for an audit for a CE mark submission.
When the CE mark is issued, sales to the European Union, Canada, China and the Australasia regions can commence. ASR will update the public when the CE mark has been officially issued. The Company expects that to occur within the next 60 days, although there can be no guarantees. The CE mark, also known as European Conformity mark, is declaration that a manufacturer's product complies with the essential requirements of the European product directives including containing essential requirements, performance levels and technical specifications in order to legally be placed on the market within the EFTA and European Union. Having the mark opens up market distribution by enabling ASR to sell product worldwide, namely in areas that the Company is pursuing, such as Canada, Europe, China and the Australasia region.
The adoption of international standards by a Company certifies to the world that Company products are of the highest quality, with widespread acceptance internationally. Abiding by ISO standards ensures products contain the most desirable characteristics including reliability, safety, efficiency, eco-friendly and affordability. Businesses who use the international standards can compete on many more markets globally, making it easier, safer and fairer for trading to ensue.
Per ISO.org, "For innovators of new technologies, International Standards on aspects like terminology, compatibility and safety speed up the dissemination of innovations and their development into manufacturable and marketable products. For consumers, conformity of products and services to International Standards provides assurance about their quality, safety and reliability. ISO standards safeguard consumers, and users in general, of products and services."
Dr. Christopher F. Tirotta, CEO and Chairman of ASR, comments, "Another exciting Company milestone has been achieved by successfully passing the world's definitive business standardized system."
vr gr willem.