Helix Medical
Helix Medical是科德宝集团旗下服务于全球医疗设备制造领域与医疗卫生企业的国际品牌
Helix Medical是全球医疗设备、卫生保健、生物制药、体外诊断(IVD)领域的领军企业,在全世界共设有6家医疗生产制造中心。Helix Medical中国公司位于深圳,于2006年建成投产。该工厂建有4个符合国际标准化组织八级标准(ISO Class 8)的无菌车间。根据客户需求,Helix Medical为客户提供量身定制的医疗设备及零部件生产与组装的服务,其中包括单一部件项目到整套承包制造在内的所有服务。位于深圳的工厂提供包括无菌车间内的模塑、组装、包装以及一系列拓展服务。2008年,工厂通过了ISO 13485质量体系认证,标志着公司达到医疗设备行业质量管理体系标准。在中国大陆地区,只有极少数公司通过这一国际标准认证。
位于深圳的Helix Medical中国工厂与美国加利福尼亚州的总部在经营管理方面有着密切协作。
Helix Medical, LLC, a division of the Freudenberg Group, is a custom manufacturer for medical device, healthcare, and pharmaceutical companies worldwide. From our beginning in 1984, our mission has been to deliver products that perform flawlessly. Nothing is left to chance. As an OEM supplier, our facilities are designed and engineered to meet or exceed FDA, GMP, and international regulatory requirements, including ISO 13485 standards. Moreover, our entire corporate culture is committed to quality and accountability.
We are also in the business of producing proprietary ENT products through our InHealth Technologies division, making it necessary to stay current with FDA regulations, ISO standards, manufacturing processes, and related issues. This gives Helix Medical an important advantage: we understand the day-to-day needs of medical device companies in a way that other contract manufacturers cannot. We also share the unique understanding of ethical and legal responsibility that comes from having your name on a product. We realize the importance of getting the job done right every time.
We invite you to learn more about Helix Medical and enjoy the peace of mind that comes from working with professionals as dedicated to quality as you are.