Medical Device Manufacturing
Protect Precision. Prevent Scrap. Keep Every Line Consistent.
Medical device manufacturing demands precision. When machines drift even slightly, tolerances shift, finishes change, and entire batches fail inspection.
Why Medical Device Manufacturing Chooses Chladni
Your production lines must meet extremely tight tolerances. Chladni gives you predictive visibility into mechanical behavior that directly affects:
Dimensional Accuracy
Extrusion Uniformity
Surface Finish Quality
Molding Consistency
Robotic Assembly Alignment
Tool Stability
The Hidden Mechanical Issues That Kill Quality
In medical device facilities, almost all quality problems start as microscopic mechanical changes.
A spindle that begins vibrating
We use your vibration data to detect:
creates chatter marks on implants
Micro-instability
A misaligned extruder
We use your vibration data to detect:
causes wall-thickness variation in catheter tubing
Micro-instability
A worn bearing
We use your vibration data to detect:
introduces friction that damages surface finish
Micro-instability
A slightly unstable laser stage
We use your vibration data to detect:
reduces weld quality
Micro-instability
A drifting servo
We use your vibration data to detect:
affects assembly alignment
Micro-instability
Explore the benefits of using Chladni
Your production lines must meet extremely tight tolerances. Chladni gives you predictive visibility into mechanical behavior that directly affects:
| Scenario | Before | With Chladni |
|---|---|---|
| Scrap Detection | Scrap shows up during QC | Drift is detected during production before scrap exists |
| Maintenance Response | Maintenance responds only after a failure | Your team gets direction days or weeks before faults escalate |
| Machine Behavior | Complex machines become unpredictable | Machines behave consistently, cycle after cycle |
| Throughput | Throughput is limited by safe speed | You can run closer to full capacity with confidence |
| Energy & Tools | High-precision lines waste energy and tools | Equipment runs smoother, cooler, and more efficiently |
The Impact Medical Device Manufacturers See
Facilities typically experience:
Fewer Rejected Parts
Fewer Rejected Parts
Fewer Rejected Parts
Fewer Tool Replacements
Fewer Tool Replacements
Fewer Tool Replacements
Tool Stability
Uneven product quality & rejected batches
Uneven product quality & rejected batches
Robotic Assembly Alignment
Rising energy costs
Rising energy costs
Extrusion Uniformity
Constant troubleshooting
Constant troubleshooting
Molding Consistency
Missing production targets
Missing production targets
How Chladni Works
Learn the Machine
The puck captures vibration and temperature continuously and learns the machine's normal behavior.
Spot the Smallest Drift
Our AI flags micro-changes that affect precision long before humans can detect them.
Understand the Root Cause
Physics-based rules identify patterns related to misalignment, tool imbalance, bearing wear, and chatter.
Predict Risk Levels
The system determines if the drift is mild, moderate, or urgent.
Tell Your Team What to Do
You receive clear guidance: what's happening, why it matters, and how to fix it.
What Teams Say
"Chladni tells us when a machine is drifting before it affects tolerances."
"We finally understand why our scrap spikes happen — and how to prevent them."
"Our CNC machines run more consistently and with fewer surprises."
"We no longer waste time chasing invisible mechanical issues."
"Chladni tells us when a machine is drifting before it affects tolerances."
"We finally understand why our scrap spikes happen — and how to prevent them."
"Our CNC machines run more consistently and with fewer surprises."
"We no longer waste time chasing invisible mechanical issues."
"Chladni tells us when a machine is drifting before it affects tolerances."
"We finally understand why our scrap spikes happen — and how to prevent them."
"Our CNC machines run more consistently and with fewer surprises."
"We no longer waste time chasing invisible mechanical issues."
"Chladni tells us when a machine is drifting before it affects tolerances."
"We finally understand why our scrap spikes happen — and how to prevent them."
"Our CNC machines run more consistently and with fewer surprises."
"We no longer waste time chasing invisible mechanical issues."
"Chladni tells us when a machine is drifting before it affects tolerances."
"We finally understand why our scrap spikes happen — and how to prevent them."
"Our CNC machines run more consistently and with fewer surprises."
"We no longer waste time chasing invisible mechanical issues."
"Chladni tells us when a machine is drifting before it affects tolerances."
"We finally understand why our scrap spikes happen — and how to prevent them."
"Our CNC machines run more consistently and with fewer surprises."
"We no longer waste time chasing invisible mechanical issues."
"Chladni tells us when a machine is drifting before it affects tolerances."
"We finally understand why our scrap spikes happen — and how to prevent them."
"Our CNC machines run more consistently and with fewer surprises."
"We no longer waste time chasing invisible mechanical issues."
"Chladni tells us when a machine is drifting before it affects tolerances."
"We finally understand why our scrap spikes happen — and how to prevent them."
"Our CNC machines run more consistently and with fewer surprises."
"We no longer waste time chasing invisible mechanical issues."
"Chladni tells us when a machine is drifting before it affects tolerances."
"We finally understand why our scrap spikes happen — and how to prevent them."
"Our CNC machines run more consistently and with fewer surprises."
"We no longer waste time chasing invisible mechanical issues."
"Chladni tells us when a machine is drifting before it affects tolerances."
"We finally understand why our scrap spikes happen — and how to prevent them."
"Our CNC machines run more consistently and with fewer surprises."
"We no longer waste time chasing invisible mechanical issues."
"Chladni tells us when a machine is drifting before it affects tolerances."
"We finally understand why our scrap spikes happen — and how to prevent them."
"Our CNC machines run more consistently and with fewer surprises."
"We no longer waste time chasing invisible mechanical issues."
"Chladni tells us when a machine is drifting before it affects tolerances."
"We finally understand why our scrap spikes happen — and how to prevent them."
"Our CNC machines run more consistently and with fewer surprises."
"We no longer waste time chasing invisible mechanical issues."
"Chladni tells us when a machine is drifting before it affects tolerances."
"We finally understand why our scrap spikes happen — and how to prevent them."
"Our CNC machines run more consistently and with fewer surprises."
"We no longer waste time chasing invisible mechanical issues."
"Chladni tells us when a machine is drifting before it affects tolerances."
"We finally understand why our scrap spikes happen — and how to prevent them."
"Our CNC machines run more consistently and with fewer surprises."
"We no longer waste time chasing invisible mechanical issues."
"Chladni tells us when a machine is drifting before it affects tolerances."
"We finally understand why our scrap spikes happen — and how to prevent them."
"Our CNC machines run more consistently and with fewer surprises."
"We no longer waste time chasing invisible mechanical issues."
"Chladni tells us when a machine is drifting before it affects tolerances."
"We finally understand why our scrap spikes happen — and how to prevent them."
"Our CNC machines run more consistently and with fewer surprises."
"We no longer waste time chasing invisible mechanical issues."
Chladni helps medical device manufacturers:
Prevent Precision-Related Defects
Reduce Energy Costs
Improve Throughput Safely
Stabilize Production Lines
Reduce Scrap and Tool Wear
Maintain High Compliance and Quality Standards
Prevent Precision-Related Defects
Reduce Energy Costs
Improve Throughput Safely
Stabilize Production Lines
Reduce Scrap and Tool Wear
Maintain High Compliance and Quality Standards
Prevent Precision-Related Defects
Reduce Energy Costs
Improve Throughput Safely
When your machines stay precise, your products stay perfect.
Stabilize Production Lines
Reduce Scrap and Tool Wear
Maintain High Compliance and Quality Standards
Prevent Precision-Related Defects
Reduce Energy Costs
Improve Throughput Safely
Frequently Asked
Questions
Will installing Chladni require us to re-validate our equipment or file a new regulatory submission?
No.Chladni is designed as a Non-Invasive Overlay.
No PLC Contact: Our sensors are completely independent of your machine’s control logic. We do not write back to the PLC or alter process parameters.
No Re-Validation: Because the installation does not impact the validated state or control strategy of the equipment, it typically qualifies as a "monitoring-only" addition, requiring no re-validation or complex change control.
How is the hardware installed? Do we need to shut down the line? A: Installation is wireless, tool-free, and requires zero downtime.
Installation is wireless, tool-free, and requires zero downtime.
Wireless & Non-Invasive: Our sensors attach to the external chassis of your assets (motors, pumps, gearboxes) using industrial-grade adhesive.
Rapid Deployment: A single line can be outfitted in under a few hours without stopping production.
Are the sensors safe for Cleanroom and GMP environments?
Yes. Our pharma-grade sensor nodes are designed with smooth, non-shedding enclosures that are IP67/IP69K rated. They are resistant to standard cleaning agents (VHP, Isopropyl Alcohol) and do not introduce particulate risk into sterile environments.
Does this system comply with Data Integrity (ALCOA+)?
Absolutely. While Chladni operates as a monitoring layer, all data is encrypted end-to-end, time-stamped, and immutable. We provide full audit trails for every alert and user interaction, supporting your site’s 21 CFR Part 11 and Annex 11 compliance strategies.
Can we integrate this data into our existing e-Logbook or MES?
Yes. We don't want to create a data silo. Chladni offers an open API to feed machine health status directly into your existing MES (e.g., Werum PAS-X, Rockwell PharmaSuite) or Quality Management System, automating the "Maintenance Required" entry in your electronic logbooks.
Will installing Chladni require us to re-validate our equipment or file a new regulatory submission?
No.Chladni is designed as a Non-Invasive Overlay.
No PLC Contact: Our sensors are completely independent of your machine’s control logic. We do not write back to the PLC or alter process parameters.
No Re-Validation: Because the installation does not impact the validated state or control strategy of the equipment, it typically qualifies as a "monitoring-only" addition, requiring no re-validation or complex change control.
How is the hardware installed? Do we need to shut down the line? A: Installation is wireless, tool-free, and requires zero downtime.
Installation is wireless, tool-free, and requires zero downtime.
Wireless & Non-Invasive: Our sensors attach to the external chassis of your assets (motors, pumps, gearboxes) using industrial-grade adhesive.
Rapid Deployment: A single line can be outfitted in under a few hours without stopping production.
Are the sensors safe for Cleanroom and GMP environments?
Yes. Our pharma-grade sensor nodes are designed with smooth, non-shedding enclosures that are IP67/IP69K rated. They are resistant to standard cleaning agents (VHP, Isopropyl Alcohol) and do not introduce particulate risk into sterile environments.
Does this system comply with Data Integrity (ALCOA+)?
Absolutely. While Chladni operates as a monitoring layer, all data is encrypted end-to-end, time-stamped, and immutable. We provide full audit trails for every alert and user interaction, supporting your site’s 21 CFR Part 11 and Annex 11 compliance strategies.
Can we integrate this data into our existing e-Logbook or MES?
Yes. We don't want to create a data silo. Chladni offers an open API to feed machine health status directly into your existing MES (e.g., Werum PAS-X, Rockwell PharmaSuite) or Quality Management System, automating the "Maintenance Required" entry in your electronic logbooks.
Will installing Chladni require us to re-validate our equipment or file a new regulatory submission?
No.Chladni is designed as a Non-Invasive Overlay.
No PLC Contact: Our sensors are completely independent of your machine’s control logic. We do not write back to the PLC or alter process parameters.
No Re-Validation: Because the installation does not impact the validated state or control strategy of the equipment, it typically qualifies as a "monitoring-only" addition, requiring no re-validation or complex change control.
How is the hardware installed? Do we need to shut down the line? A: Installation is wireless, tool-free, and requires zero downtime.
Installation is wireless, tool-free, and requires zero downtime.
Wireless & Non-Invasive: Our sensors attach to the external chassis of your assets (motors, pumps, gearboxes) using industrial-grade adhesive.
Rapid Deployment: A single line can be outfitted in under a few hours without stopping production.
Are the sensors safe for Cleanroom and GMP environments?
Yes. Our pharma-grade sensor nodes are designed with smooth, non-shedding enclosures that are IP67/IP69K rated. They are resistant to standard cleaning agents (VHP, Isopropyl Alcohol) and do not introduce particulate risk into sterile environments.
Does this system comply with Data Integrity (ALCOA+)?
Absolutely. While Chladni operates as a monitoring layer, all data is encrypted end-to-end, time-stamped, and immutable. We provide full audit trails for every alert and user interaction, supporting your site’s 21 CFR Part 11 and Annex 11 compliance strategies.
Can we integrate this data into our existing e-Logbook or MES?
Yes. We don't want to create a data silo. Chladni offers an open API to feed machine health status directly into your existing MES (e.g., Werum PAS-X, Rockwell PharmaSuite) or Quality Management System, automating the "Maintenance Required" entry in your electronic logbooks.
Will installing Chladni require us to re-validate our equipment or file a new regulatory submission?
No.Chladni is designed as a Non-Invasive Overlay.
No PLC Contact: Our sensors are completely independent of your machine’s control logic. We do not write back to the PLC or alter process parameters.
No Re-Validation: Because the installation does not impact the validated state or control strategy of the equipment, it typically qualifies as a "monitoring-only" addition, requiring no re-validation or complex change control.
How is the hardware installed? Do we need to shut down the line? A: Installation is wireless, tool-free, and requires zero downtime.
Installation is wireless, tool-free, and requires zero downtime.
Wireless & Non-Invasive: Our sensors attach to the external chassis of your assets (motors, pumps, gearboxes) using industrial-grade adhesive.
Rapid Deployment: A single line can be outfitted in under a few hours without stopping production.
Are the sensors safe for Cleanroom and GMP environments?
Yes. Our pharma-grade sensor nodes are designed with smooth, non-shedding enclosures that are IP67/IP69K rated. They are resistant to standard cleaning agents (VHP, Isopropyl Alcohol) and do not introduce particulate risk into sterile environments.
Does this system comply with Data Integrity (ALCOA+)?
Absolutely. While Chladni operates as a monitoring layer, all data is encrypted end-to-end, time-stamped, and immutable. We provide full audit trails for every alert and user interaction, supporting your site’s 21 CFR Part 11 and Annex 11 compliance strategies.
Can we integrate this data into our existing e-Logbook or MES?
Yes. We don't want to create a data silo. Chladni offers an open API to feed machine health status directly into your existing MES (e.g., Werum PAS-X, Rockwell PharmaSuite) or Quality Management System, automating the "Maintenance Required" entry in your electronic logbooks.