Expert Medical Device Testing Lab Services

Medical device testing can include vibration, mechanical shock, environmental exposure, thermal shock, fatigue, load/displacement, pressure, tensile, compression, torsional, and quality assurance testing. The right combination depends on the device function, materials, intended environment, transport conditions, and validation objectives. B83 Testing & Engineering helps define practical test methods that support design verification and product reliability decisions.

Yes. B83 Testing & Engineering is an ISO/IEC 17025:2017 accredited testing laboratory recognized by ANAB, the ANSI National Accreditation Board. This accreditation demonstrates technical competence, controlled procedures, calibrated measurement practices, and quality system discipline for accredited testing activities. It supports manufacturers that need reliable, defensible data for design validation, quality assurance, and risk reduction.

Vibration and shock testing help verify that medical devices can withstand shipping, handling, installation, and operating conditions without functional or structural failure. These tests can reveal loose components, resonance issues, cracking, connector weakness, or packaging vulnerabilities. Early testing helps manufacturers reduce warranty risk, improve design robustness, and document performance before product release.

Environmental testing exposes devices or components to controlled temperature, humidity, altitude, or thermal shock conditions to evaluate performance stability and material durability. It can identify problems such as condensation sensitivity, seal degradation, warping, cracking, electronic malfunction, or dimensional change. These results help manufacturers understand how a device may perform under real-world storage, transport, and use conditions.

Timelines vary based on test complexity, fixture requirements, sample availability, chamber or shaker scheduling, and reporting needs. Straightforward testing may move quickly once the test plan is defined, while custom development or multi-condition programs require more coordination. B83 is known for flexible scheduling and accommodating changing client demands whenever possible.

Yes. B83 Testing & Engineering provides unique fixture design and custom test development capabilities for complex products, components, and assemblies. Custom fixtures help mount samples accurately, replicate real-world constraints, and achieve meaningful test results. This is especially useful when standard setups do not properly represent the way a medical device is installed, handled, or loaded.

Testing can help reduce liability, warranty costs, insurance exposure, and product failure risk by identifying weaknesses before release. It also supports improved customer satisfaction, stronger quality assurance, and more confident design decisions. For medical device manufacturers, documented testing provides valuable evidence that products have been evaluated against defined performance, durability, and safety expectations.

B83 serves companies from many industries and regions, including medical device and machine manufacturers across the United States and worldwide. Clients can coordinate test requirements with the Milwaukee-based laboratory team, provide samples and specifications, and receive technical support throughout the process. The lab’s independent, engineer-owned model is designed for collaborative, long-term testing partnerships.