Coronado Industries Announces Successful Completion of ISO 13488 Certification Process.Business Editors/Health/Medical Writers FOUNTAIN HILLS, Ariz.--(BUSINESS WIRE)--Jan. 12, 2004 An Essential Part of the Company's European Manufacturing and Distribution Plan is Firmly in Place Coronado Industries Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : CDIK), announced today that the company has been notified that they have been certified as fully compliant with the EN 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. 13488 standards in regards to the manufacture and distribution of ophthalmic medical devices. This international standard covers a host of the company's internal and external manufacturing, compliance and reporting systems, including manufacturing, distribution, installation and servicing. The EN ISO 13488 quality standards were specifically implemented to cover medical devices. Richard Smith Richard Smith is the name of:
About 300 of the standards produced by ISO and IEC's Joint Technical Committee 1 (JTC1) have been made freely/publicly demonstrate the high manufacturing and quality standards we are committed to. Our customers also appreciate that our systems are regularly audited and are capable of meeting these high standards." Smith said that the successful completion of the EN ISO 13488 certification process marks another milestone for the company's international marketing and distribution efforts. "Being able to meet the ISO 13488 quality standard was key in our efforts to bring PNT PNT Point PNT Paint (MacPaint graphic file format) PNT Patient PNT Pentagon (Washington, DC; US DoD) PNT Positioning, Navigation and Timing PNT Prime Number Theorem PNT Phenytoin to the marketplace. Full compliance with all applicable international standards is critical in order to allow us to be in a position to manufacture and distribute the company's patented Glaucoma glaucoma (glôkō`mə), ocular disorder characterized by pressure within the eyeball caused by an excessive amount of aqueous humor (the fluid substance filling the eyeball). Treatment Device within the European Community European Community: see European Union. European Community (EC) Organization formed in 1967 with the merger of the European Economic Community, European Coal and Steel Community, and European Atomic Energy Community. and elsewhere following receipt of the necessary regulatory approvals," he said. Dr. John Sharkey, Coronado's director of operations, noted that the certification would allow the company's Fountain Hills production site to manufacture and distribute other active and passive medical devices. "Ophthalmic medical devices are considered 'critical' medical devices under the guidelines. Having met the higher standards to act as a manufacturer and distributor of ophthalmic medical devices, our facilities can also serve as a manufacturing and distribution site for active and passive medical products in general. With the successful completion of the ISO 13488 certification process we are now in a position to also manufacture and distribute medical products for other medical device companies which may open up additional business opportunities for Coronado Industries," he said. In recent months, Coronado Industries has signed marketing and distributor agreements covering Italy, Spain, Portugal and North Africa. "We are making headway and the interest level from other international distribution companies in obtaining exclusive distribution rights for our PNT technology continues to grow," said Smith. "The successful completion of the ISO 13488 certification process can only add to the desire of the company's management team to complete the remaining registration processes and to bring new distributors on board in Europe and in other markets around the world," he said. Coronado Industries has, for seven years, been dedicated to its patented Glaucoma Treatment Device. Through its wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. , Ophthalmic International, it focuses on the development of its patented procedure as a cost-effective alternative for the treatment of the most common types of glaucoma, which are open angle and pigmentary. Forward-looking statements in this release are made pursuant to the "safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Investors are cautioned that such forward-looking statements involve risks and uncertainties, including without limitation, continued acceptance of the company's products, increased levels of competition for the company, new products and technological changes, the company's dependence on third-party suppliers, and other risks detailed from time to time in the company's periodic reports filed with the Securities and Exchange Commission. |
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