Our commitment to quality
We don’t compromise the standards we set, no matter what.
As an additive manufacturing contract manufacturer, we want to make life as easy as possible for our customers. We do that by having 100% confidence that our parts meet the requirements and by simplifying the regulatory pathway. As a result, we enable our customers to shorten their time-to-market and to eliminate costs related to non-conforming parts.
Eliminate cost of non-quality by getting conforming parts, every time.
Obtain hurdle-free approvals for your products through our FDA Master File.
Shorten your time-to-market by leveraging Amnovis' knowhow and expertise on 3D printing.
Our customers leverage our 3D printing expertise.
Talk to us to find out how our existing solutions can make your life easier, or how we can create a solution for you.
ISO 13485:2016 certified
We built a robust quality management system.
Learn how we give you confidence in every part.
We supply products for the US market.
FDA Master File
A great way to simplify your regulatory pathway.
One of our core values is to commit to quality. Put simply, this means we don’t compromise the standards we set, no matter what.
We built a robust quality management system: an ecosystem of organizational and operational reliability, putting state-of-the-art tools and equipment in the hands of our competent employees.
To support our strategic focus on high-end, quality-critical applications such as medical devices, Amnovis' quality management system is ISO 13485:2016 certified by SGS Belgium NV since August 2021.
We combine our thorough understanding of product specifications and process capabilities with state-of-the-art metrology and material testing methods to give you 100% confidence in every single part that gets shipped.
the regulatory pathway
Bringing new products to the market is a rigorous process, as is making significant changes to optimize your critical processes, materials, and suppliers. At Amnovis, we understand the efforts that are required in this process, and we do our part to simplify the pathway as much as possible.
This is why, apart from our ISO 13485:2016 certification, we are also registered as a medical device contract manufacturer with the FDA, and we have made all intricacies on the critical aspects of our qualified 3D printing processes directly available through a Master File.
FDA Master File
Amnovis CP Ti
A pure titanium validated without heat treatment.
Ti-6Al-4V grade 23
The most used alloy for 3D printed titanium implants.
Thermally resistant plastic for surgical guides.