Industry Spotlight: How Medical Device Manufacturers Benefit from Inline Thermographic Inspection
Why Medical Devices Require More Than Sampling
Traditional inspection methods like random testing and visual checks are no longer enough when:
Weld quality affects sterility or containment
Devices are subject to FDA, MDR, or ISO 13485 audits
Single-use parts must be 100% reliable
Manufacturers need digital documentation for every unit
Even small deviations in thermal input during welding can compromise long-term reliability - especially under temperature or pressure cycles in the field.
Inline Thermography as a Validation Tool
TherMoPro from LPKF is especially developed for high quality laser welding of plastics and uses infrared thermography to measure the surface temperature distribution of every part immediately after welding. This allows:
Non-destructive, real-time inspection
Detection of under- and overheated zones
Verification of homogenous energy input across the weld seam
Logging of more than 20 thermal parameters per part
Unlike destructive testing, this method supports continuous validation without damaging any production parts - ideal for batch release and process control. However, the full power lies in the software.
Traceability and Audit Readiness Built In
Every measured part is assigned a unique ID, and its thermal profile is logged. This creates a fully auditable record that includes:
Time of production
Machine and process parameters
Pass/fail classification
Any deviations or warnings from defined thresholds
This data is digitally stored, secure, and exportable—meeting typical requirements for ISO 13485, GxP, or FDA 21 CFR Part 11 environments.
Proven Use in Medical Applications
TherMoPro has been successfully evaluated in multiple high-precision medical manufacturing environments, including:
Disposable diagnostic cartridges
Insulin delivery systems
Drug inhalers
Sensor housings
The system provides non-contact, particle-free, and substrate-neutral inspection, making it ideally suited for cleanroom-compatible processes and sensitive product designs.
Instead of relying on manual or destructive quality checks, TherMoPro enables the automatic detection of non-welded or incorrectly welded parts by analyzing deviations in thermal input.
Ideal when quality is key: LPKF’s Thermography
Medical device manufacturing demands zero-defect performance. With inline thermographic inspection, manufacturers gain the confidence, transparency, and documentation they need to meet today’s compliance standards and tomorrow’s patient expectations.