Mar 4, 2016 | By Alec

As regular readers will have doubtlessly noticed, medical 3D printing is steadily revolutionizing the way academic surgeons are approaching complex surgeries. Especially surgical models are playing a vital role in optimizing the success rate of unconventional surgeries, though this isn’t taking place on a very large scale. Especially in the EU and the US, harsh restrictions limit the use of certain materials and procedures, and specific certifications are required to produce medical equipment. It’s therefore great news that Dutch medical 3D printing specialists Oceanz has just become the first 3D printing company to be awarded the ISO 13485-certificate from the EU, paving the way for medical 3D printing on a large scale.

Oceanz is an Ede-based 3D printing service that provides numerous high quality 3D printing solutions, though they have been especially focused on medical applications. Back in September 2014, they became the first company within the 3D printing industry to be awarded the ISO 9001 certificate, which denoted their ability to provide high quality 3D prints.

For ISO 9001, organizations need to demonstrate that they can been certain regulatory requirements and apply systems effectively, as well as have the right staff, facilities and equipment to guarantee a specific manufacturing quality. It also necessitates regular inspections. The plus side is that customers have a quality guarantee. EU laws are very strict when it comes to the manufacturing of medical tools and instruments and, in a nutshell, the ISO 13485-certificate is the medical version of the ISO 9001. It shows that manufacturers meet all the demands necessary for the production of medical instruments and is also internationally accepted.

As the company revealed, they managed to meet the quality demands of the ISO certificate through a systematic quality enhancement policy. During the extensive audit, they proved to work on an adequate level to merit the certificate. The certificate, awarded by certification and inspection organization LRQA/Lloyds, is valid for three years and requires an annual audit. “Over the past few months, we here at Oceanz have implemented several policy changes. Completely corresponding to protocol, we have set up a separate clean production space, where all employees follow all rules. This ensures a clean manufacturing process and no chance of contamination,” they say.

Aside from overall manufacturing quality, several specific medical safety demands were also required. This was the case for, among others, registrations involving customer and legal demands, research and development, packaging and labelling, product identification and retracing possibilities. With the certificate, Oceanz proves that all of these fields are covered. “By receiving the ISO 13485 certificate, we are further distinguishing ourselves in the market. It was our main goal, as it proves our dedication to conform quality and the legal demands that accompany medical 3D printing,” said Erik van der Garde, the company’s director. “Through our quality management system, we are offering our medical clients more reliability and quality. It also provides possibilities for new markets, and Oceanz is thus working to further the professionalization process of the 3D printing industry.”

The company further argued that medical 3D printing is the future. Surgeons, dentists, researchers and medical instrument manufacturers can all benefit from the technology to provide more accurate and efficient care. Patients, they say, can directly benefit from the technology, and they believe a revolution will take place within the next five years.

Right now, the company provides pre-surgical models, product molds, surgical molds and medical instruments, the last two of which have received ISO 13485 certification. 3D prints in PA2200 and PEBA materials meet ISO 13485 demands right now. Other materials offered by Oceanz include PA 3200 GF, Prime Part ST, Alumide and CarbonMide, all 3D printable on SLS 3D printers. All, they say, have excellent material properties, good chemical resistance, biocompatibility. and a very high level of accuracy.

The company has already said there’s a significant demand for ISO 13485 3D prints, and are already requesting clients to mention the certificate in their orders so they can ensure that parts are also medically sealed for shipping.



Posted in 3D Printer Company



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Florian wrote at 3/7/2016 10:14:12 PM:

First in 2016 ... funny news. Maybe in the Netherlands?

Alberto Cajiao wrote at 3/7/2016 12:10:52 PM:

I agree with Paul D'Urso. In our case, 3D Systems Layerwise obtained these certifications in 2009.

Paul D'Urso wrote at 3/5/2016 10:01:32 AM:

This article is wrong! Anatomics was established 20 years ago and achieved ISO accreditation 3 years ago! Please withdraw this article as it is misleading or at least acknowledge this fact. Paul D'Urso Founder of Anatomics

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