Leading Test Solutions for Medical Devices
ECG, NIBP, Sp02, and temperature monitors ▪ Implanted devices like pacemakers and defibrillators ▪ Ambulatory/portable monitoring (pH, ECG, NIBP, blood glucose) ▪ Ventilators and telemetry devices ▪ Cable and lead wire systems (ECG, catheters, device cables) ▪ Surgical devices ▪ Endoscopes ▪ Team support for system validation (V&V) and FDA compliance, including IQ/OQ/PQ ▪ And more.
There are many factors that influence medical-device product quality for the life sciences industry. Rest assured that our dedicated test development team shares the same passion as you do – the need to ensure the highest-quality patient care through the best medical-device designs, documentation and test equipment possible.
Over the years we have partnered with many Global 1000 companies and start-ups to successfully test and document diverse products. Due to this wide-ranging experience, Averna excels at high-tech solutions for every stage of the product lifecycle, including design verification, new product introductions (NPI), and production testing.
Our portfolio of test services and solutions includes automated test equipment, modular instruments, swappable fixtures, build-to-print, vision inspection systems, and integration into production lines. And at every step of the way we can support your quality and FDA-type regulatory approval processes. We also offer solutions for managing your test and quality data to improve decision-making, processes and products.
Challenge: Is there technology more life-critical than medical devices? That's why testing is crucial and why there's so much FDA-type oversight. Every player needs to get it right.
Solution: We collaborated with Spacelabs on advanced test stations for 10 products. Our solutions included standardized HW, PXI, swappable fixtures and LabVIEW/TestStand software.