Oceanz professional 3D printing company has won the first in the industry ISO 13485 certificate. This recognition has put a professional step in the medical 3D printing industry.
European legislation imposes strict requirements on the production of medical devices. The ISO 13485 certification is the medical version of ISO 9001, specially developed for medical device manufacturers to meet guidelines. The Quality Management System ISO 13485 : 2003 is accepted worldwide and industry wide .
Oceanz has issued a formal quality policy for obtaining the certificate. During the audit Oceanz has demonstrated to perform a level of quality that it has been recognized by leading certification and inspection body LRQA / Lloyds. The ISO certificate is valid for 3 years with Lloyds conducting an audit annually.
Besides the practical implementation there are also sector-specific requirements for medical devices. This applies to records related to customer and legal requirements, research and development, packaging and labeling, product identification and the possibility to convert. Oceanz has shown certification to have all these things and actions in order.
Erik van der Garde , director of Oceanz , is very proud of this certification: "By receiving the ISO 13485 certificate, we are further distinguishing ourselves in the market. It was our main goal, as it proves our dedication to conform quality and the legal demands that accompany medical 3D printing. Through our quality management system, we are offering our medical clients more reliability and quality. It also provides possibilities for new markets, and Oceanz is thus working to further the professionalization process of the 3D printing industry."
Source and top image: Oceanz