Sculpteo Secures ISO 13485 Certification, Expanding Opportunities in Medical Manufacturing

By on June 3rd, 2024 in Corporate, news

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Sculpteo achieves an ISO certification [Source: Fabbaloo / LAI]

Sculpteo announced they’ve achieved a critical certification that could grow their business significantly.

The certification in question is ISO 13485, which deals with medical product manufacturing. This particular standard is concerned with ensuring quality results for biomedical manufacturing applications.

ISO 13485 is quite similar to the more widespread ISO 9001, but includes provisions for continuous improvement.

According to Wikipedia:

“Compliance with ISO 13485 is often viewed as the initial step in ensuring adherence to European regulatory requirements. This is particularly significant when it comes to assessing the conformity of Medical Devices and In-vitro Diagnostic Medical Devices in accordance with European Union Directives 93/42/EEC, 90/385/EEC, and 98/79/EEC before allowing their sale.”

Certifications are critically important for service bureaus, as they open up the possibilty for more customers. Consider the case of a company requiring a medical product component to be produced. They literally cannot use any service that does not have the required certifications — it’s almost as if they are not customers or even prospects.

This changes for Sculpteo with the addition of the new certification, which will almost certainly attract more medical application projects.

My suspicion is that Sculpteo would have customers in this area ready to go — that could be why they introduced the certification. If they received contacts requesting the ability to produce medical components that were being turned away, then why not get the certification?

That seems to be exactly what Sculpteo did here.

Via Sculpteo

By Kerry Stevenson

Kerry Stevenson, aka "General Fabb" has written over 8,000 stories on 3D printing at Fabbaloo since he launched the venture in 2007, with an intention to promote and grow the incredible technology of 3D printing across the world. So far, it seems to be working!