Oceanz成欧洲首家获ISO13485认证的3D打印公司
发布时间: 2016-03-07 16:36 点击：
Oceanz成欧洲首家获ISO13485认证的3D打印公司
Oceanz into Europe's first 3D certified ISO13485 printing company
在欧美地区，关于医疗设备的各方面限定非常之多，包括材料，生产程序等等。近日，荷兰医疗3D打印企业Oceanz获得了欧盟颁发的ISO13485认证，成为了欧洲首家获此认证的3D打印公司，为其业务的进一步扩张埋下了重要的铺垫。
In Europe and the United States, all aspects of medical equipment is limited, including materials, production procedures and so on. Recently, the Holland medical 3D printing company Oceanz won the EU's ISO13485 certification, becoming the first European 3D printing company for this certification, for the further expansion of its business has laid an important foundation.
作为一家3D打印服务商，Oceanz的业务重要集中在医疗应用方面，2014年，该公司取得了ISO9001 认证，是其3D打印机一张重要的名片。
As a 3D printing service provider, Oceanz's business is important in medical applications, in 2014, the company achieved ISO9001 certification, is its 3D printers an important business card.
ISO13485相当于医疗界的ISO 9001，获得此认证的公司被认为具有具有生产医疗设备的所有必须条件，该公司此次获得认证的产品包括3D打印手术模具和3D打印医疗工具，值得一提的是，欧盟在颁发此认证时异常严格，能获得它的公司并不多，该认证也是在国际范围都有效的。
ISO13485 is equivalent to the medical community of ISO 9001, access to the certification of the company is believed to have with all the production of medical equipment necessary conditions, the company obtained certification of products, including 3D printing operation mold and medical 3D printing tools, worth mentioning is, EU issued by the certification is very strict, for the company is not much, the certification is in the international scope are effective.
自此，Oceanz成为了获得此项认证的第一家欧洲3D打印公司，称得上是一条绝对优势，在其他竞争对手中脱颖而出，也是该公司的目标之一。随着医疗3D打印市场的飞速发展，Oceanz定能在将来的舞台上占得一席之地。
Since then, Oceanz became the first European 3D printing company to obtain this certification, it is an absolute advantage in other competitors to stand out, but also one of the goals of the company. With the rapid development of the medical 3D printing market, Oceanz will be able to occupy a place on the stage in the future.
ISO13485 ISO13485 certification ISO134852012 quality management system ISO13485 the latest version of ISO13485 ISO13485 standard download