Industry Spotlight: How Medical Device Manufacturers Benefit from Inline Thermographic Inspection

In medical device manufacturing, the requirements are always high: quality failures can impact lives. Every welded component - whether part of a diagnostic cartridge, inhaler, or implantable system - must meet stringent safety, cleanliness, and documentation requirements. Thermographic Inspection offers manufacturers of medical plastic assemblies a powerful tool to ensure 100% quality control, full traceability, and validated processes - all without slowing down production. But to meet the highest demands, thermographic systems should be more than just a simple camera tool.

Deep dive into TherMoPro – Read the Whitepaper

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.

Learn More About TherMoPro

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.