Amnovis provides end‑to‑end additive‑manufacturing services for regulated industries, selecting laser‑powder‑bed‑fusion or stereolithography processes and certified materials such as Ti‑6Al‑4V and high‑conductivity copper alloys. The company operates a fully digital, ISO 13485‑certified production platform with integrated metrology, cloud‑based traceability, and an FDA Master File to streamline regulatory approval and enable scalable, repeatable part production.
Funding
Funding not disclosed
Founders
Product
Problem
Regulated high‑tech industries such as medical devices and advanced industrial equipment require precision‑engineered, metal‑additive‑manufactured parts, but they often lack in‑house expertise to select appropriate AM technologies, maintain strict quality certifications, and scale production without costly non‑conforming parts. Traditional AM contract manufacturers can be slow to adapt, rely on paper‑based processes, and provide limited visibility into regulatory compliance, leading to delayed time‑to‑market.
Solution
Amnovis operates as a full‑service additive‑manufacturing contract partner that bridges the gap from concept to FDA‑compliant, ISO‑13485‑certified production. The company evaluates each project to identify the optimal laser‑powder‑bed‑fusion (LPBF) or stereolithography (SLA) technology and material grade, then implements a paperless, digitally automated workflow that tracks every step of the build, post‑processing, and inspection. Proprietary metrology and material‑testing protocols deliver 100 % confidence that each part meets specification, while an FDA Master File simplifies regulatory submissions for customers. Engineers work alongside clients to define repeatable production workflows, and the agile organization can scale volume quickly without sacrificing traceability or quality. All data are stored in a secure cloud environment, enabling real‑time reporting and seamless integration with customers’ quality management systems.
Target Audience
Primary customers are OEMs and contract developers in regulated sectors—particularly medical‑device manufacturers (e.g., implant and surgical‑guide producers) and industrial firms requiring high‑performance metal components such as aerospace, defense, and energy equipment.
Features
- Technology selection engine that matches part geometry and performance requirements to Ti‑Grade 1, Ti‑6Al‑4V (Grade 23), high‑conductivity copper alloys, or Accura Phoenix SLA resin
- End‑to‑end digital production platform with 100 % paperless work orders, automated build scheduling, and real‑time status dashboards
- ISO 13485:2016 certified quality management system and FDA‑registered Master File for streamlined regulatory approval
- Integrated metrology suite (CT, laser scanning, material testing) providing statistical process control and part‑by‑part traceability
- Comprehensive post‑processing line including CNC machining, grinding, bead blasting, cleaning, and sterile packaging
- Scalable cloud‑based analytics that generate conformity reports, trend analysis, and predictive maintenance alerts
- Secure data exchange via encrypted APIs compatible with customers’ ERP and QMS platforms