How Wet Testing Enhances Accuracy and Reliability in Medical Device Manufacturing

Why Wet Testing Is Essential for Medical Device Performance

Bringing a medical device to market involves much more than innovation. It requires rigorous testing to ensure each product meets strict standards for precision, safety, and regulatory compliance. Wet testing is a critical part of this process, especially for devices used in diagnostics, therapeutics, and surgical procedures. This type of testing simulates real-world clinical conditions by using biological materials and challenging the device's key functions. At Spartronics, we conduct wet testing with precision and purpose, ensuring every device meets FDA and ISO standards before it reaches the hands of patients or healthcare providers.

What Wet Testing Involves

Wet testing verifies a device’s performance using real or simulated biological samples. These include reagents, calibration materials, control materials, and human or animal samples. Conducted after device assembly and calibration, wet testing serves as a final check to confirm that the device performs as intended under clinical-like conditions. This independent verification helps ensure reliability and safety before release.

The Impact of Wet Testing on Product Quality

Wet testing plays a vital role in identifying any performance issues early in the process. It challenges the most critical device functions such as thermal regulation, fluid dispensing, mixing accuracy, and diagnostic range detection. If failures occur, they are analyzed and documented, enabling root cause identification and ongoing quality improvement. This process safeguards against future issues and supports a cycle of continuous innovation and refinement.

Why Spartronics Is the Right Partner for Wet Testing

Not all contract manufacturers are equipped to perform wet testing in the production environment. Our facilities are designed to meet strict GMP standards, with calibrated equipment, controlled environments, and robust documentation processes that ensure traceability throughout the product lifecycle.

With FDA registration and ISO 13485 certification, Spartronics offers a turnkey solution that brings together assembly, calibration, wet testing, and final verification under one roof. This integrated approach streamlines the entire production process and ensures consistent product quality.

Strategic Advantages of Wet Testing at Spartronics

Centralizing wet testing at Spartronics offers clear benefits. It reduces product handling, simplifies inventory management, minimizing the need to send the product elsewhere for final testing. It also supports faster implementation of design updates and facilitates refurbishment or direct to end-customer shipping. Co-locating the product build and final test of your product at Spartronics can lead to shipments direct to distribution. 

Strongsville: A Dedicated FDA-Certified Facility

Our Strongsville, Ohio facility plays a key role in our wet testing capabilities. As an FDA-registered and ISO 13485-certified site, it is purpose-built for medical device manufacturing. This location operates as a dedicated high-level assembly (HLA) contract manufacturing site, equipped to meet the complex needs of regulated industries. Customers benefit from experienced technicians, comprehensive quality systems, and full traceability from design through delivery.

Design Services That Drive Testing Success

Spartronics doesn’t just manufacture and test, we support product development from the ground up. Our design and engineering teams collaborate with customers early in the development cycle to ensure devices are built for manufacturability and regulatory compliance. This proactive approach reduces rework, accelerates time to market, and ensures a smooth transition from design to testing and production. With design and manufacturing integrated under one roof, Spartronics is uniquely positioned to deliver scalable solutions for even the most complex medical devices.

Conclusion

Wet testing is a crucial element of medical device development and release. Choosing a contract manufacturing partner with in-house wet testing capabilities results in higher product quality, regulatory confidence, and a faster path to market. Spartronics combines decades of industry experience with a full-service approach to bring your medical device to life.

Contact us to learn more about how Spartronics can support your next medical device program with expert-level wet testing and full-service manufacturing capabilities.