Polyzen Earns Top Level Medical Industry Certification |
(Archive News Story - Products mentioned in this Archive News Story may or may not be available from the manufacturer.)
Polyzen, Inc.
1041 Classic Rd.
Apex, NC, 27539
USA
Press release date: February 7, 2006
Awarded ISO 13485 Certification to Open Doors to More Finished Device Business
APEX, NC 02/07/2006- Polyzen, Inc., a leading developer and manufacturer of medical balloons, tissue barrier sleeves and other disposable medical products and devices for medical industry OEMs, has achieved ISO 13485 certification. As such, the firm has taken major steps toward becoming a major player in finished medical devices.
According to company President, Tilak M. Shah, "By investing to earn this top level medical standard, Polyzen customers can be assured that we offer most of the medical industry's highest levels of quality, service, support and management. This achievement enables us to greatly expand our services with our offering a broader range of finished goods. This is in addition to helping them design and manufacture key medical components."
By earning ISO 13485 Certification, one of the medical industry's most stringent standards, firms are recognized for having developed the highest quality procedures and documentation. These include certification of systems to monitor and maintain the effectiveness of all processes, the adherence to strict documentation according to special management system manuals, the highest level of quality control and full documentation records to prove that requirements have been met, among other criteria.
Polyzen, Inc. is now in its 15th year as one of the medical products industry's pre-eminent manufacturers of critical and specialty disposable components and devices, as well as a leading contract manufacturer for medical product OEMs. It was founded by President Tilak M. Shah, who is regarded worldwide as the pre-eminent expert on thermoplastic polyurethane elastomers. There are breakthrough products that are being used more and more widely in medical products as alternatives to PVC and latex (the latter which are arguably less suitable for contact with patients and medical personnel). In addition, Mr. Shah and his company have earned numerous patents for products and techniques in the medial products industry.
For further information on either the new ISO 13485 standards awarded Polyzen, or their products and services, contact: Marketing Department, Polyzen, Inc., 1041 Classic Road, Apex, NC 27539. Tel: (919) 319-9599. Fax: (919) 319-8428. E-mail: info@polyzen.com. Web Site: www.polyzen.com.
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