Testing Medical Devices
Supporting the medical devices industry from design to submission
Helping Our Customers Make Advances in Healthcare
Medical devices are defined in the EU MDR as instruments, apparatus, appliances, software, implants, reagents, material or other article intended by the manufacturer to be used, alone or in combination, for humans for one or more specific medical purposes.
Testing Medical Devices
Regulation of medical devices
Within Europe, a Medical Device can only be placed on the market or put into service if it complies with the European Medical Device Regulation (EU 2017/745). Other markets have corresponding regulations which are regulated locally, for example by the MHRA in the UK and the FDA in the USA. These regulations ensure that products on the market are safe and perform as intended.
Types of tests
Testing of Medical Devices can include efficacy testing for devices with an antimicrobial or antiviral claim, or biocompatibility testing to show that the device is not harmful to humans. For products used in the disinfection of medical devices, there are suspension and carrier tests specifically for the medical area.
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
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Contact us today to explore how we can support you with your next project.