ISO 13485 certification paves way for Oceanz to apply life-saving medical 3D printing technology on a global scale
Founded in 2011, Oceanz is an Ede-based 3D printing company that provides high quality 3D printing solutions. Known for their relentless focus on innovation, Oceanz’s services have touch points across a range of industries, from retail goods to complex industrial design and engineering.
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.
Asked why it was important for the company to obtain both ISO 9001 and ISO 13485 certifications, Erik van der Garde, Director of Oceanz, said, “ISO 13485 certification denotes our ability to 3D print medical grade plastics in an environment that meets all internationally-accepted production demands. But having certification to ISO 9001 also brings with it further business benefits as it reflects a commitment to customer service and continuous process improvement. Through our dual quality management systems, we are in a stronger position to offer our medical device clients more reliability and quality.”
To learn more, click here to download the full case study.