Trusted Medical Device Leak Testers
Medical device manufacturers know that Good Manufacturing Processes (GMP) and FDA quality matrix means that you cannot cut corners ensuring the clinical safety and reliability of medical devices. Thorough testing and application knowledge of medical equipment is required to ensure that each device functions as it is designed to perform. Consult an engineer today to learn more about our medical device leak and flow testers.
Medical Leak Test Systems
Unlike off-the-shelf mass-produced leak detectors, InterTech’s patented nondestructive testing instrumentation for FDA-regulated manufacturers is optimized for GMP manufacturing environments - including Test Method Validation (TMV).
Medical Leak Testing Applications
InterTech’s medical leak testing equipment is proven to be the most cost-effective test technology for a wide range of medical devices and medical products such as:
Medical Leak Testing Systems
InterTech’s MED75 Series Leak Detectors are engineered for high-speed medical device leak testing, ensuring precise and reliable results for critical products. These compact mass flow instruments are optimized to reduce cycle time while achieving superior measurement capability.
- InterTech’s proprietary leak test technology eliminates the errors (both false positives and false negatives) inherent in previously used pressure testing methods.
- Ethernet/IP capability of test instruments allows seamless integration of test data with all quality assurance systems.
- Remote access features create significant savings in maintenance, product change-over times.
- A robust product quality traceability system is assured by the implementation of a deterministic analytical test technology. lifecycle.
- 21 CFR 11 data requirement compatibility are built into InterTech test instruments and testing solutions. This protects manufacturers and end-users from negative product safety events.
frequently Asked Questions
The Med75 platform can test under 10 seconds depending on micro leak accaptance criteria
Yes, our testers are designed to reliably handle complex and flexible geometries such as IV bags, syringes, and wound‑care devices.
Our systems use temperature compensation algorithms to ensure testing accuracy under varying environmental conditions.
Consult Our Experts
Please contact InterTech for further information or help with your test application. We are happy to answer any questions you may have. Give us a call at 847-679-3377 or fill out the form and we'll be in touch as soon as possible.
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