Download Oceanz Case Study for Medical Devices

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 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, they also became the first company of its kind in the Netherlands to hold dual ISO 9001 and ISO 13485 certifications.

Benefits of ISO 13485 certification, beyond compliance

Whilst top management at Oceanz recognised that obtaining ISO 13485 certification was essential as a means to do business, they placed more emphasis on the true value that ISO 13485 certification would bring, especially to its clients – an assurance of the company’s commitment to delivering its products and services with a high level of quality, safety and consistency.

“With ISO 13485 certification, we are able to further differentiate ourselves in a highly competitive and intensely regulated medical device market. It also demonstrates to our clients that top management is fully committed to quality excellence through continual improvement,” concluded van der Garde.