2023-06-01 12:16:32
Amnovis accelerates the certification process for 3D printed titanium implants by working with an FDA Master File. This includes extensive AM process knowledge and experience with titanium 3D printing that the Belgian contract manufacturer has acquired. Customers can thus significantly speed up their admission process to the American market.
The FDA Master File covers critical aspects of Amnovis’ qualified 3D printing processes for standard and patient-specific devices using validated Ti grade 1 and Ti-6Al-4V grade 23 materials. The knowledge and experience with 3D printing of titanium implants have been incorporated into the master file. By working with this, customers do not have to go through this step themselves. Ruben Wauthle, CEO and co-founder of Amnovis, says this removes an important barrier to 3D printing for manufacturers of medical titanium implants.
Shorter time-to-market
“Having an FDA Master File is another milestone for our company and fits perfectly with our strategy to produce high-end products for quality-critical and high-tech applications. This allows our customers to shorten their time to market and eliminate the cost of non-conforming parts,” says Ruben Wauthle. He expects that this will accelerate the adoption of additive manufacturing as a production technology for medical implants.
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