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.