In the medical world, 3D printing is being applied more and more, for example unique bones and skull, medical instruments, medical devices and disposables are printed. 3D printing is widely applicable within the medical field. Thanks to this technique, surgeons, dental technicians, researchers and manufacturers of medical devices can work more efficiently and accurately. But it also has benefits for the patient! For example, 3D printed patient specific medical devices ensure that surgery is more efficient and effective. 3D printing is decreasing the costs of care.
Are you working in a hospital, pharmacy or on duty as a (family) doctor? And do you have an idea for a medical instrument, device or model where 3D printing can offer a solution? Oceanz helps you to realize this as a qualified 3D print professional. With success, due to Oceanz working together with several Academic Hospitals in the Netherlands. The development of a medical device, instrument or model usually requires a lot of perseverance, patience and development costs. Oceanz tackles such a project together with you and already has good examples and results in that field area. In order to guarantee quality, Oceanz connects the process to your ISO standard or CE quality mark.
Oceanz was the first 3D printing company in the Netherlands to acquire the ISO 13485 certification. With this recognition a professional step has been taken within the medical 3D printing industry. European legislation imposes strict requirements on the production of medical devices. The ISO 13485 certificate is the medical version of ISO 9001, specially developed to allow manufacturers of medical devices to comply with these medical guidelines. The quality management system EN ISO 13485: 2003 is accepted worldwide and sector-wide.
The ISO certificate is a standard that sets requirements for the quality management system of an organization. Oceanz has set up an official quality policy for obtaining the certificate. During the audit, Oceanz demonstrated a level of quality management that was recognized by the renowned certification and inspection institution LRQA / Lloyds. The ISO certificate is valid for 3 years. LRQA / Lloyds conducts an audit every year.
In addition to the practical implementation within the standard, sector-specific requirements on medical devices also apply. This applies to, among other things, registrations relating to customers and legal requirements, research and development, packaging and labeling, product identification and possibility of tracing back. Oceanz has shown through the certification to have all these things and actions in order.