ISO13485医疗器械认证,申请医疗器械（CMDC）企业应具备的条件
ISO13485 certification for medical equipment, medical equipment ( CMDC ) enterprises should have the conditions
1、申报企业应持有工商行政部门颁发的法人营业执照或注册文件。
In 1, an applicant enterprise shall hold is industrial and commercial administrative departments issued by the legal person business license or registration documents.
2、申报企业的产品或质量体系的覆盖的产品应符合有关国家标准或行业标准要求并已注册，产品已定型且已成批生产。
2, declaration of enterprises or products quality system covering products shall comply with the relevant national standards or industry standards and has been registered, products have been stereotyped and already batch production.
3、申报企业应建立符合ISO9001系列标准及IS013485：2003（YY/T0287-2003）专用要求的质量保证体系，并已正式运行，进行过至少二次全面内部审核及一次管理评审。
In 3, declaring the enterprise should establish a series of ISO9001 standards and IS013485: 2003 ( YY / T0287-2003 ) and special requirements of the quality assurance system, and has been officially running, had at least two times overall internal audit and management review.
4、质量体系所覆盖的产品/服务质量稳定，能正常批量生产/服务，并提供充分的质量记录。
4, quality system covering the product / service quality is stable, can normal production / services, and provide full quality records.
5、在提出申请前的一年内，申报企业质量体系覆盖的产品无重大顾客投诉事故。
In 5, prior to the filing of the application within one year, declaring the enterprise quality system covering the products without significant customer complaints accident.