Header – Medical devices

Medical Equipment Testing

De-risk medical device testing and FDA approvals with quality test solutions

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.

Functional & Regulatory Testing

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

  • 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
Technicians at Medical Manufacturing Plant

Specialized Medical Device & Equipment Testing

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.

Advanced Test System Design

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.

  • 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)
  • Centralized dashboards for real-time test visibility and data integrity
  • Integration with MES, ERP, and QA environments

Our systems grow with your product line and regulatory complexity.

 

Purpose-Built Test Platforms for Power & Energy Applications

 

Lens Module Test Platform

The Lens Module Test Platform is a flexible solution to deliver the quality that is expected from your brand for all types of lenses and cameras. Configure it to measure objective, eyepiece or camera lenses.

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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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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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BLE & RF Testing Tools

Bluetooth Low Energy (BLE) Technology has revolutionized the use of wireless devices in life sciences. Characteristics like power consumption, data rate and range make it a reliable protocol for hundreds of medical devices. Testing these devices can be a challenge on their own, so here are more details on the technology.

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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. 

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Why trust our expertise at Averna

With 25+ years in test engineering and a strong footprint in Europe and North America and Asia, Averna has supported the successful launch of dozens of Class II and III medical devices, from surgical robotics to connected wearables.

And we’re not just here for a test bench; we support you across the lifecycle of your product. Beyond technical know-how, we bring a deep understanding of the quality expectations that shape the life sciences industry. We collaborate closely with you to ensure every testing challenge becomes an opportunity to improve reliability

Our partners were satisfied

Empatica chose to work with Averna because they were looking for a test partner who could ramp up quickly and meet their timelines. With the EmbracePlus ready for production, the manual testing they were conducting prior would not allow them to meet their volume demand. Averna’s medical test expertise combined with their mechanical engineering proficiency made them the perfect fit for this challenging project.

Test station with Averna Launch screen

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

White Paper Thumbnail - Did Visual Inspection Delay the Vaccine?

 

White Paper

This white paper examines the validation process through vision inspection system of glass vials and rubber components for medical vials.

Cover - Reliability and Consistency for Surgical Success

 

Success Story

Discover how our suite of test systems ensures flawless accuracy, and how we helped this medical giant launch the market’s most precise surgical assistant through advanced robotic integration testing.


 

eBook

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

Simply Compliance with Averna

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