3D printing is widely used in the medical field. Surgeons, dental technicians, researchers and manufacturers of medical devices can work more efficiently and more accurately thanks to this technique. But patients benefit from it as well! For example, 3D printed patient-specific medical devices make surgery more efficient and more effective. 3D printing makes healthcare cheaper.
What can you 3D print for medical?
Do you work in a hospital, pharmacy or as a (general) practitioner? And do you have an idea for a medical instrument, device or model for which 3D printing could be the solution? As a qualified 3D printing professional, Oceanz helps you bring it to life. With success, because Oceanz now works 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 takes on such a project together with you with the support of our already good examples and results. To guarantee and secure quality, Oceanz aligns the process with your ISO standard or CE mark.
Medical 3D printing and ISO 13485
Oceanz is the first 3D printing company in the Netherlands to obtain the ISO 13485 certification. This recognition marks a professional step 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 and was specifically developed to enable manufacturers of medical devices to comply with these medical directives. The quality management system EN ISO 13485:2016 is accepted worldwide and branch-wide.
3D print quality on a high level
The ISO certificate is a standard that imposes requirements on an organisation’s quality management system. Oceanz has drawn up an official quality policy for the purpose of obtaining the certificate. During the audit, Oceanz demonstrated a level of quality management that was recognised by the renowned certification and inspection body LRQA/Lloyds. The ISO certificate is valid for 3 years. LRQA/Lloyds performs an annual check-up audit.
Oceanz and MDR
Oceanz complies with the new MDR, a stringent European directive for medical device manufacturers. Every type of medical device sold in the EU must undergo a conformity assessment to demonstrate that all requirements have been met. The risk class of the medical device determines the conformity assessment route. The new regulation for medical devices (MDR 2017/745) will apply from 26 May 2021.
More than quality
In addition to the practical implementation within the standard, sector-specific requirements also apply to medical devices. These include customer and regulatory requirements, research and development, packaging and labelling, product identification and traceability. Oceanz has demonstrated with its certification that it has all these issues and actions in order.
On-de 3D printing models for the medical sector
- Surgical guides (ISO 13485)
- Medical instruments (ISO 13485)
- Preoperative models
- Machining jigs
- Practice models