Medical Device Testing Services

Supporting the medical devices industry from design to submission

Helping Advance Innovation in Healthcare

Virologica provides expert medical device testing services to support manufacturers throughout the product lifecycle, from early-stage development to regulatory submission. Our team works closely with medical device companies to generate the high-quality data needed to demonstrate safety, performance, and compliance.

Medical devices are defined under the European Medical Device Regulation (EU MDR 2017/745) as instruments, apparatus, appliances, software, implants, reagents, materials, or other articles intended by the manufacturer for use, alone or in combination, for specific medical purposes in humans.

Testing Medical Devices

Regulation of medical devices

Before a medical device can be placed on the market in Europe, it must comply with the European Medical Device Regulation (EU MDR 2017/745). Similar requirements exist in other regions, including regulations overseen by the MHRA in the UK and the FDA in the United States. Compliance with these regulatory frameworks helps ensure that medical devices are safe, effective, and perform as intended.

As an experienced medical device testing laboratory, Virologica supports manufacturers with testing strategies designed to meet regulatory requirements and accelerate market access.

Types of Medical Device Testing

Our medical device testing services include efficacy testing for products making antimicrobial or antiviral claims, as well as biocompatibility testing to demonstrate that devices are safe for human use. We also provide specialist testing for products used in the cleaning and disinfection of medical devices, including suspension and carrier tests developed specifically for healthcare applications.

With expertise in virology, microbiology, and cell biology, Virologica delivers reliable data to support product development, regulatory submissions, and commercial success.

Why Virologica

Providing quality, expert testing services

Knowledge

Our scientists are experienced in working with medical devices across the disciplines of virology, microbiology and cell biology.

Quality

We understand how important each test is to you and our team is committed to delivering high-quality data.

Flexible

We can work with you to design a method for your project or adapt current standards for novel devices.

Communication

We provide realistic timelines from the outset and keep you in the loop if anything changes.

Selection of Relevant Standards

ISO 10993-5 Cytotoxicity

Tests for in vitro cytotoxicity.

EN 16777

Quantitative non-porous surface test without mechanical action for the evaluation of virucidal activity of chemical disinfectants used in the medical area

ISO 20776

Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices

What Our Customers Say…

“Customers needed to know that harmful viruses could be completely removed from our medical device prior to reuse. Virologica’s rigorous experimental protocol quickly delivered the clear and reliable evidence we needed.”

Technical Manager, Healthcare Business

Frequently Asked Question

What is medical device testing and why is it important?

Medical device testing evaluates the safety, performance, and effectiveness of a product before market release. It helps manufacturers meet regulatory requirements and generate evidence needed for approvals and customer confidence.

What types of medical device testing services are available?

Medical device testing services can include biocompatibility, antimicrobial and antiviral efficacy, microbiology, virology, and performance testing. The required tests depend on the device type, intended use, and regulatory pathway.

How do medical device testing laboratories support regulatory compliance?

Medical device testing laboratories generate data to support compliance with regulations such as EU MDR, MHRA, and FDA requirements. Testing helps demonstrate that devices are safe and perform as intended.

When is biocompatibility testing required for a medical device?

Biocompatibility testing is often required when a medical device comes into direct or indirect contact with the human body. It helps assess potential biological risks and supports regulatory submissions.

Can a medical device testing lab assess antimicrobial or antiviral claims?

Yes, a medical device testing lab can evaluate antimicrobial and antiviral claims using recognised test methods. This testing provides evidence to support product performance and regulatory documentation.

How long does medical device testing typically take?

Testing timelines vary depending on the device, test requirements, and applicable standards. An experienced medical device testing laboratory can help define a suitable testing plan and expected timeframe.

Why choose an ISO 17025 accredited medical device testing laboratory?

An ISO 17025 accredited medical device testing laboratory operates under recognised quality standards and validated procedures. Accreditation helps ensure reliable, reproducible results for regulatory and commercial needs.