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Artes Medical通过ISO 13485:2003质量体系认证


管理员  | 2013-04-21 15:20:09

(BW)(CA-ARTES-MEDICAL)Artes Medical通过ISO 13485:2003质量体系认证;获得质量体系认证也是获得CE-Marking和加拿大CMDCAS批准的第一步

美国商业新闻2006年1月5日圣迭戈消息――

Artes Medical一家专注于开发、制造与商业化新型永久性可注射整容产品的综合性医疗技术企业,今天宣布其已经通过ISO 13485:2003质量体系认证,符合这项国际公认的医疗设备制造商质量体系标准的要求。

Artes Medical加入了那些已经通过了ISO 13485:2003质量体系认证的国际知名医疗设备制造商的行列。ISO 13485:2003质量管理体系要求组织有能力始终如一地提供最高质量水准的产品与服务。ISO 13485:2003认证是公司达到相关医疗设备监管与法规要求,进而获得欧盟CE-marking和加拿大批准的第一步。

Artes Medical总裁兼首席执行官Stefan Lemperle医学博士说道:“Artes Medical的品质策略是力争对所有业务流程进行不间断改进。获得ISO 13485:2003质量体系认证是企业获得的一项重大成就。Artes致力于为客户提供最高标准的品质,希望能够将系统、流程与产品提高到下一水平。我们计划在2006年申请获得欧洲CE-marking和加拿大CMDCAS批准。”

ISO 13485:2003是一项由国际标准组织(International Organization for Standardization)制定的独立医疗设备质量体系标准,针对那些重视监管质量体系要求的医疗设备行业设计。

关于Artes Medical, Inc.

Artes Medical是一家关注用于皮肤病与整形外科市场的新型可注射美容产品的开发、生产与商业化的综合性医疗技术企业。企业的领先产品ArteFill?以企业拥有专利的Aesthetic Tissue Engineering(TM)平台为基础,企业还以同一平台为基础开发出了其他产品。

ArteFill是由精细过滤微球粒(Precision-Filtered Microspheres?)组成的无与伦比的组合,其甚至于能够悬浮在纯牛胶原(Purified Bovine Collagen?)当中。ArteFill能够刺激人体内自然胶原的生成,从而能够塑造体形与消除皱纹。ArteFill的上市审批申请(PMA)已经得到了美国食品药物管理局(FDA)的批准。一旦ArteFill最终获得批准,它将会成为首个同时也是唯一通过美国食品药物管理局批准的永久性可注射微植入物,用来治疗被称为微笑纹或者鼻唇沟的脸部皱纹。

Artes Medical总部位于加利福尼亚州圣迭戈市,创立于1999年,是一家私营控股企业。了解关于企业与产品的更多信息,请访问网站 www.artesmedical.com 。Artes Medical和ArteFill是属于Artes Medical, Inc所有的注册商标。

联系方式:Schwartz Communications Nigel Smith或者Christine LaMontagne 电子邮件:artes@schwartz-pr.com 415-512-0770或者781-684-0770

(BW)(CA-ARTES-MEDICAL) Artes Medical Obtains ISO 13485:2003 Quality System Certification; Quality System Certificate First Step to CE-Marking and Canadian CMDCAS Approvals

SAN DIEGO--(BUSINESS WIRE)--Jan. 5, 2006--

Artes Medical, a fully-integrated medical technology company focused on the development, manufacture and commercialization of a new category of permanent injectable aesthetic products, today announced it has received a quality system certificate demonstrating compliance with ISO 13485:2003, the internationally recognized quality system standard for medical device manufacturers.

Artes Medical joins the ranks of internationally renowned medical device manufacturers who have obtained ISO 13485:2003 quality system certificates. ISO 13485:2003 specifies quality management system requirements for an organization to demonstrate its ability to consistently provide products and services at the highest level of quality. The ISO 13485:2003 certificate is the first step towards demonstrating compliance with appropriate medical device regulatory and statutory requirements for CE-marking in the European Union and for Canadian approval.

"The quality policy for Artes Medical is to strive for continuous improvements in all of our business practices. Obtaining this ISO 13485:2003 quality system certificate is a major achievement for the company. Artes has shown a commitment to the highest standard of quality for our customers and the desire to advance our systems, processes and products to the next level," said Stefan Lemperle, M.D., President and CEO of Artes Medical. "We plan to apply for CE-marking for Europe and Canadian CMDCAS approval in early 2006."

Developed by the International Organization for Standardization, ISO 13485:2003 is a stand-alone medical device quality system standard especially intended for the medical device industry focusing on regulatory quality system requirements.

About Artes Medical, Inc.

Artes Medical is a fully-integrated medical technology company focused on the development, manufacture and commercialization of a new category of injectable aesthetic products for the dermatology and plastic surgery markets. The company's lead product ArteFill(R) is based on the company's proprietary Aesthetic Tissue Engineering(TM) platform from which other products will be developed.

ArteFill is a unique combination of Precision-Filtered Microspheres(TM) evenly suspended in Purified Bovine Collagen(TM). ArteFill stimulates the body's own natural collagen production to build volume and achieve enduring wrinkle correction. ArteFill's pre-market approval application (PMA) has been deemed approvable by the FDA. Once ArteFill receives final approval, it will be the first and only FDA-approved permanent injectable micro-implant for the treatment of facial wrinkles known as smile lines or nasolabial folds.

Based in San Diego, Calif., Artes Medical was founded in 1999 and is privately-held. Additional information about the Company and its products are available at www.artesmedical.com. Artes Medical and ArteFill, are registered trademarks of Artes Medical, Inc.

CONTACT: Schwartz Communications Nigel Smith or Christine LaMontagne Email: artes@schwartz-pr.com 415-512-0770 or 781-684-0770

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