ISO 13485 certification paves way for Oceanz to apply life-saving medical 3D printing technology on a global scale.
Oceanz’s ‘Selective Laser Sintering’ printing technology is revolutionising the medical industry on many fronts, bringing with it the potential to manufacture medical devices more efficiently, more cheaply, and more sustainably than conventional manufacturing processes. The prosthetic arms and legs that Oceanz manufactures can be tailor-made with such precision that they are attuned to the patient’s unique anatomy and respond to even the slightest physical need. Oceanz’s 3D printed models of vital human organs are also shifting the way that academic surgeons approach complex surgeries, boosting the success rates of high-risk operations and enabling them to provide more efficient healthcare solutions, thereby benefiting the patients directly.
Oceanz’s quality journey – a series of ‘firsts’ Oceanz is no stranger to ‘firsts’.
On 10 March 2016, when Oceanz became the first 3D printing company in the Netherlands to receive certification against the world’s most popular standard for medical devices quality management system, ISO 13485 (Medical devices – Quality management systems – Requirements for regulatory purposes), they also became the first company of its kind in the Netherlands to hold dual ISO 9001 (Quality management systems – Requirements) and ISO 13485 certifications.
Download the full case study ▼