Covalon Recommended for ISO 13485:2003 Certification.MISSISSAUGA, Ontario -- Covalon Technologies Ltd. (Covalon) (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension VENTURE:COV COV Composés Organiques Volatiles (French) COV Compuestos Orgánicos Volátiles (Spanish: Volatile Organic Compounds) COV Coefficient of Variation COV City of Villians (game) ) is extremely pleased to announce that independent auditors, BSI Management Systems  This article or section is written like an .Please help [ rewrite this article] from a neutral point of view. Mark blatant advertising for , using . , have inspected the quality management system governing the company's facility, and are recommending certification of Covalon under 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. This is an important milestone in terms of reaching global markets:
- ISO 13485 is required to obtain Health Canada approval;
- ISO 13485 is required for the CE mark in most markets outside of
North America; and
- Most global medical product manufacturing/distribution companies
are ISO 13485 certified and require that their vendors are also
certified.
ISO 13485 is the international quality management standard for designers and manufacturers of medical devices and related services, and is harmonized with the U.S. FDA's good manufacturing practices. Certification indicates that a company has quality management systems processes in place that have been assessed for their ability to meet customer and regulatory requirements. Covalon Technologies Ltd. is a company with advanced medical products that has developed and patented advanced therapeutic biomaterials for wound care and surgical applications and coatings. Polymer chemistry and surface coating technology have been combined to create a range of time-release drug delivery platforms that are applied to many medical devices to treat many critical conditions. A variety of applications for these technologies have been identified and specific products have been developed. The products offer features and benefits providing solutions to many of the problems caused by current devices and their material properties which are used by most medical device manufacturers and suppliers. The problems include infection, poor biocompatibility biocompatibility the quality of not having toxic or injurious effects on biological systems. biocompatibility 1. The extent to which a foreign, usually implanted, material elicits an immune or other response in a recipient 2. , and microbial microbial pertaining to or emanating from a microbe. microbial digestion the breakdown of organic material, especially feedstuffs, by microbial organisms. attachment. The TSX Venture Exchange TSX Venture Exchange Originally called the Canadian Venture Exchange (CDNX), this was a result of the merger of the Vancouver and Alberta stock exchanges. The goal of TSX Venture Exchange is to provide venture companies with effective access to capital while protecting investors. has in no way passed upon the merits of the proposed transaction and has neither approved nor disapproved of the contents of this release. The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. Covalon Technologies Ltd. (TSX VENTURE:COV) |
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