From 1 to
1,000,000 Parts
With 100% Traceability
AMiRIS provides the real-time insights and a complete digital thread to support medical device production, from patient-specific implants to high-volume orthopaedic components.
Regulatory Standards are Evolving. Are you Ready?
The Regulatory Shift
Increasingly regulators and industry leaders are moving towards a new standards for AM medical devices that is process aware. The focus is shifting from material equivalence (510K) to a process aware certification pathway.
To scale production effectively, manufacturers must be able to prove that every part, on every machine, is made to the highest standard.
The Critical Question:
How do you capture the unique aspects of metal additive manufacturing, while building a scalable, traceable, and cost-effective for every single part you produce?
Go Beyond Pass/Fail. Unlock Your Production Potential.
The AMiRIS Platform: Your Foundation for Scalable Production
Achieve Full Traceability & Compliance
AMiRIS generates a complete, auditable "digital thread" for every part. This layer-by-layer data provides the objective evidence needed to validate your process, satisfy global regulators, and build confidence in your production output.
Optimise & Scale Your Production
Turn data into performance. Use deep process insights to fine-tune machine parameters, reduce build times, and increase yield. AMiRIS gives you the tools to move from single-machine operations to a fully optimised, multi-machine production line.
Enable the Future of Manufacturing
Build the foundation for distributed manufacturing. With a verified and traceable process, you can confidently replicate production across different machines and locations, opening the door to a more agile and resilient supply chain.
Eliminate Waste & Reduce Costs Today
Why wait for a post-build CT scan to find a flaw? Our in-situ monitoring detects deviations as they happen, dramatically cutting material waste, machine time, and costly post-processing analysis, delivering immediate ROI.
Precision Where It Matters Most
Orthopaedic Implants
Knees, Hips, Spinal Frames
Challenges:
Surface finish requirements, complex lattice geometries, fatigue life validation
AMiRIS Benefit:
Ensure the integrity of every component and lattice strut to validate the quality of production devices. AMiRIS gives you the confidence to print complex, high-value devices at scale.
Patient Specific Devices
Custom and one-off devices
Challenges:
Unique designs, rapid turnaround requirements, reliability validation
AMiRIS Benefit:
Validate the quality of unique geometries and surgical guides without extensive destructive testing. Deliver trustworthy and reliable devices fast.
Secure Your Production. Lead the Industry.
Don't let regulatory uncertainty slow down your innovation. Implement the gold standard of quality assurance for metal additive manufacturing and gain a competitive edge today.