Amnovis simplifies regulatory submission for 3D printed titanium implants
Medical device OEMs worldwide benefit from faster time-to-market in the US through Amnovis’ FDA Master File
Aarschot, Belgium – May 24, 2023.
In its FDA Master File, Amnovis elaborates on all critical aspects of its qualified titanium 3D printing processes for Ti grade 1 and Ti-6Al-4V grade 23. This way, Amnovis proactively addresses typical FDA concerns about these processes, which simplifies the regulatory submissions of 3D printed titanium implants in the USA for medical device OEMs worldwide. The information contained in the extensive FDA Master File comprises the unmatched expertise of Amnovis' founders in titanium 3D printing and the operational excellence of the Amnovis team.
Amnovis is widely seen as an innovative Additive Manufacturing (AM) contract manufacturer. Its founders have a background in manufacturing high-end AM products since 2008. They were among the first to employ laser powder bed fusion (LPBF) for printing titanium medical devices. Its extensive AM expertise and experience enables Amnovis to remove hurdles in medical device development, validation and manufacturing.
A frequent hurdle for medical device OEMs is addressing FDA concerns about the 3D printing process as part of their regulatory submission of medical devices. To avoid potential delays and issues with approvals for the US market, Amnovis has incorporated its extensive AM process expertise and experience with titanium 3D printing into a FDA Master File. This greatly facilitates the regulatory submission for 3D printed titanium implants for Amnovis customers. The Master File covers critical innovation 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.
Ruben Wauthle, Amnovis CEO & Co-founder: "Having an FDA Master File is a new milestone for our company and perfectly fits with our strategy of manufacturing high-end products for quality-critical and high-tech applications. Guided by our commitment to quality, we are ISO 13485 certified and combine our thorough understanding of product specifications and process capabilities with state-of-the-art metrology and material testing methods. As a result, we enable our customers to shorten their time-to-market and to eliminate costs related to non-conforming parts.”
“As a company, we continuously want to redefine the state-of-the-art for 3D printed medical devices, and at the same time make our unique process knowhow and expertise more readily available to customers worldwide, like we do with our FDA Master File. In the end, this helps the adoption of 3D printed medical devices, which offer more added value for patients and provide them higher degrees of comfort and mobility.”
Bert Engelen (left), Operations Manager, and Ruben Wauthle (right), CEO & Co-founder of Amnovis
Founded by Peter Mercelis and Ruben Wauthle and based in Belgium. Amnovis is a manufacturing and engineering company that uses innovative additive manufacturing (AM) technologies and materials for high-end applications such as medical devices. As an ISO 13485 certified contract manufacturer, Amnovis offers best-in-class AM technologies and expertise and paves the way for emerging AM technologies and materials. Digital process automation provides the traceability and repeatability to flexibly scale up manufacturing of products that comply with customer and regulatory requirements.