Medical Equipment Quality Testing - Medical Devices

The Testing & Compliance Hurdles MedTech Teams Face

Compliance is not optional. In a field where a malfunction can cost lives, testing must be exhaustive. But the complexity of devices continues to grow - wireless protocols, miniaturized sensors, AI-driven interfaces - while regulatory expectations remain rigid.

As a result, teams are under pressure to validate faster without compromising safety. And yet, all too often, testing processes are manual, fragmented or poorly documented. This is a bottleneck for innovation and a liability during audits.

Our Medical Device Testing Services

From proof of concept to final production, Averna supports life science and medical device companies with customized testing services that speed time to market. Our systems are designed to fit your processes, whether you're launching a new surgical platform, testing portable diagnostic devices or extending packaging inspection lines.

We want to guarantee the efficiency of all patient care products. At every stage of the process, we can help you ensure quality and compliance with FDA-type regulatory approvals.

Averna’s Specialized Expertise in Life Sciences

Averna brings together advanced engineering, domain-specific knowledge, and flexible tools to cover the entire testing lifecycle of your medical devices. Below are some of the areas where we help teams like yours move faster.

We help ensure your products perform reliably and comply with international medical standards. This is ideal for manufacturers preparing Class II & III devices for submission.

Every product is unique, and so are your test needs. That’s why we offer flexible, modular, and build-to-print solutions tailored to your production context.

Functional & Regulatory Testing

V&V testing for embedded software, electronics, and system functionality
Automated medical packaging inspection
IQ, OQ, and PQ validation aligned with FDA, CE, and Health Canada expectations
Electrical safety testing and insulation verification
RF testing and wireless protocol validation in compliance with IEC 60601-1-2
EMC testing preparation and mitigation
Complete traceability and documentation for audits and approvals

Advanced Test System Design

Automated test stations for single or multi-device testing
Modular hardware platforms with swappable fixtures
Custom fixturing for high-mix / low-volume production
Cable & interconnect test systems (ECG wires, catheters, internal leads)
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Centralized dashboards for real-time test visibility and data integrity
Integration with MES, ERP, and QA environments

We Valide and Test Various Medical Devices

Infographic - Medical - Life Science Applications 2025

We help test and validate many different medical devices such as:

ECG, NIBP, SpO2 & temperature monitoring systems
Surgical devices, robotic platforms, and imaging tools
Implanted electronics like pacemakers and defibrillators
Portable diagnostic and ambulatory monitoring systems (pH, glucose, ECG)
BLE-connected tester and battery-powered devices
Endoscopes, ventilators, and telemetry instruments
Everything we validate is done under real-world use conditions.

Lens Module Test Platform

A Flexible solution for precise measurements for lenses as small as 2 mm3. From endoscopes to surgical robots, configure it to measure objective, eyepiece or camera lenses.

See the system

Battery Testing for Med Sector

A working battery can mean the difference between life and death. Don't take chances with quality, see what our experts can offer for battery cell, module or pack testing.

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Packaging Vision Systems

Pharma and medical packaging requires the same consideration as the product itself. There is only one way to meet compliance, assure quality, lower costs and get to market quickly.

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BLE & RF Testing Tools

Characteristics like power consumption, data rate and range make Bluetooth Low Energy a reliable protocol for hundreds of medical devices.

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Let’s Talk About Your Medical Testing Needs

Designing a new diagnostic platform? Validating a robotic system? Need help navigating IQ/OQ/PQ? 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.

Why Trust our Expertise at Averna

With decades of experience and a reputation for exceptional customer support, we partner closely with your teams from concept to deployment, ensuring every solution is aligned, supported. We work at the intersection of advanced engineering and operational reliability.

25+ Years in Medical Test Engineering

From surgical robotics to connected wearables, we've supported the successful launch of dozens of Class II and III devices across a tightly regulated landscape.

Smart Data Management

Our systems structure and centralize test data so your teams have what they need to prove quality and respond to audits with confidence.

Rapid Ramp-Up, Without Compromise

Partners like Empatica chose us because we mobilize quickly and hit production timelines without cutting corners on compliance or quality.

Full Lifecycle Support

We stay engaged from proof of concept through production, adapting our modular platforms as your device and its regulatory requirements evolve.

Cover - A Total Health Monitor on the Go

To support the rapid scale-up of a next-generation wearable health monitor, Averna developed for Empatica an automated test system capable of validating a wide range of biomedical sensors within tight production cycles. The solution replicates real-world physiological conditions while ensuring high-speed, repeatable validation across all device functions.

End-to-end validation of multimodal biosensors using controlled stimuli and skin-mimicking environments
High-density functional testing including Bluetooth, charging, display, haptics and communication interfaces within a single compact station

This validation approach creates a reliable and scalable production test environment, ensuring medical-grade data accuracy while supporting rapid industrialization of wearable devices.

Below 90 sec Validation per Unit

32 mm Diameter of the DUT

12 Biomarkers & Sensors to Track

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