Test Labs starts 2023 with further growth in medical device validation services
Already one the fastest-growing laboratories in the UK, Test Labs is increasing the support and services we offer to the medical device manufacturing sector. As a specialist laboratory for medical device testing, we are focused on ensuring the supply of compliant medical devices, which is currently undergoing fresh challenges.
MDR certification support
We have developed a validation service for reusable surgical instruments. This service fully complies with the requirements of the MDR 2017/745, which has replaced the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMD).
The current shortage of Notified Bodies authorised to grant MDR 2017/745 has created a backlog that risks leaving manufacturers without valid certification to cover their products after the MDR deadlines. The Test Labs validation service helps to streamline the new application process with high-quality, reliable data for the technical files that must accompany each application.
At Test Labs, we start validation studies within a week of receiving customers’ samples and our industry-leading turnaround times deliver validation results within four weeks.
Unique purpose-built testing facilities
To facilitate streamlined testing and validation, we have 3,000 square feet of open microbiology, material science and chemistry laboratory space under one roof.
These facilities play a key role in enabling simulated use studies when validating medical device instructions for use (IFU) and allow us to assess product compatibility by simulating a medical device’s lifecycle in Highly Accelerated Life Tests (HALT). As our state-of-the-art test chambers have been designed to fit whole products (e.g., hospital beds, etc.), with the largest one being 65m3 and smallest one being 12m3, we are able to test a wide variety of different products. Additionally, all test chambers are equipped with environmental monitoring stations that track various environmental parameters during the HALT study: within these test chambers we can create almost any environmental conditions and expose test items to real-world use.
Test Labs continues to grow scope of accreditation
Test Labs have started the year with a new standard under our UKAS scope – BS8628:2022 released to test UVC disinfection systems – making us the only lab in the UK with this accreditation. Test Labs is also the only laboratory in the UK that can offer purpose-built test facilities that are UKAS-accredited for both EN17272:2020 and BS8628:2022.
As a result of this, Test Labs has tested multiple devices under both standards and gained a level of expertise invaluable to manufacturers seeking accreditation.
Explore how we can support your medical device journey to the market
Clinical Evaluation
We develop and implement procedures to collect, appraise, and analyse clinical data pertaining to your medical device.
Reusable medical device reprocessing
Our team will evaluate your procedures for manual and automatic cleaning, disinfection and sterilization.
Disinfection products for medical devices
We test the efficacy of a wide range of disinfectants for medical devices, including disinfection technologies and robots.
