De-Risk Medical Device Testing and FDA Approvals with Quality Test Solutions

 LIFE SCIENCE

Image of results coming from an X-rays or CT scan (computed tomography scan) or MRI (magnetic resonance imaging) or ultrasound. The front of the image shows a display of results and the medical machine is shown in the background. nuclear medicine imaging, including positron-emission tomography (PET)

Quality RF Solutions for MedTech

With the emergence of Bluetooth Low Energy (BLE) and other commercial protocols, see how you can leverage our RF and quality expertise through every stage of the product lifecycle, including design verification, new product introductions (NPI), IQ/OQ/PQ, and production testing.

Image mainly displays the telementry monitor of a patient showing heart rate, blood pressure, ECG and Respitory results. In the background doctors are shown working on the patient.

Efficiency for All Patient-Care Products

At every step of the way we can support your quality and FDA-type regulatory approval compliance. From custom instrumentation, vision inspection or smart solutions to manage all test and quality data, our solutions improve decision-making, manufacturing processes and product quality.

Image of the test station produced for Spacelabs healthcare. The Device under test is shown in front of the test station, with a PC attached for easy access to smart test data leveraging proligent. The station manages the digital threads for 10 different products.

Trust Averna - A 3rd-Party Integrator

Because we operate independently, we are able to combine various technologies to create the ideal solution for your requirements. Our extensive portfolio includes automation, design, Build-to-Print and more. And if the technology you need does not exist yet, we’ll happily develop it for you.

From implanted or surgical devices to monitors, ultrasounds and scopes, talk to our test and quality experts about our medical-device test solutions, documentation and expertise.

Sketch of an ear, using an RF hearing aid to amplify sound. The signals coming from the medical device are shown.

Proven Turnkey Test Solutions & Global Support

Deliver the highest-quality patient care through the best medical-device designs, documentation and test equipment.

Learn More About our Advanced Medical Test, Measurement and Quality Solutions 

Image of the cover for a case study on a successfully executed project for hearing implants. The project produced a fully automated test station producing standardized test results, and features completely modular and reusable components. Implant Malfunctions are completely eliminated.

Success Story

Learn about our 100% reliable, automated test system that provides standardized test results which features completely modular and reusable components.

Link to a free ebook reviewing the top 5 trends in medical devices testing for the medtech industry. It is a guide of how to reduce challenges and maximize ROI and Quality.

eBook

Download our eBook on industry trends like personal medical devices, increased industry regulations, and increased RF capabilities.

Image of a case study to demonstrate how we engineered a high-speed, automated Vision System that processes more than 1,000 units per minute. See how we ensure  brand protection with a fast time to market in the medtech industry.

Success Story

Learn how we engineered a high-speed, automated Vision System that processes more than 1,000 units per minute. See how we ensure  brand protection with a fast time to market.

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 ▪ Automated test equipment ▪ Modular instruments ▪ Swappable fixtures ▪ Build-to-print services ▪ Vision inspection systems ▪ And more.
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Averna's leading Test & Quality solutions ensure client products get to quality, market and margin faster than ever.

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