Test Labs for Medical Device Quality & Regulatory Affairs Consultants
We work with medical device regulatory affairs consultants, supporting their clients with their testing and validation needs
We want to get and keep your client’s medical devices on the market!
Your clients are constantly challenged with regulatory and operational demands and it doesn’t help when the regulatory landscape keeps on changing, creating confusion and frustration.
We understand this. That is why we work hand in hand with you to deliver the results you require – fast.
Here are 3 things you can expect from us:
1. Responsiveness from the Get-Go
You can spend a lot of time waiting to hear back from other laboratories. When time is in
short supply with looming MDR deadlines, we don’t want you to spend time waiting.
We reply to all enquiries straight away, literally within minutes of receiving them.
To match the urgency and demand in the market for high-quality, reliable data that you need to have in your technical file, we have increased our laboratory capacity and we want to work with you.
2. Immediate Results
Like a relay race, we want to hand over the data baton as fast as we can so you can continue to soar through your medical device journey roadmap.
We designed our lab to produce rapid and reliable data, some would say we simply can’t wait to get your products approved.
You understand the importance of objective evidence in your products technical file – we know what standards to apply to get that data.
3. Rock Solid Reliability
Did you know, we’re the guys that got UKAS accreditation in a record-breaking time?
We are experts when it comes to achieving compliance, which is why our Quality Management Systems ensure the data we produce for your device is rock solid.
Reliable data is key to ensuring Notified Bodies do not pick holes in your application. We are a faster and more reliable option for your clients medical device.
You will be supported by a Medical Device CRO with a testing laboratory accredited to ISO 17025
We keep microbiology, material science, and chemistry expertise all under the same roof – it enables us to provide you with the speed of service that will keep your product momentum on it’s journey to the market. Test Labs is a boutique medical device contract research organisation with an ISO 17025 laboratory accredited by UKAS (No.22215). Our dedicated team offers undivided attention, providing you with intelligent insights enabling your clients to make the right decisions, save money and ultimately, save a patient’s life.
See some of our medical device testing services:
IEC 60601-1 Pre-Compliance Evaluation
We test your device, mitigating the cost of repeated compliance testing by evaluating potential non-compliances.
Medical device biocompatibility testing
We offer tests which evaluate cytotoxicity and biological risks within the chemical make-up of a medical device.
Reusable medical device reprocessing validation
Our team will evaluate your procedures for manual and automatic cleaning, disinfection and sterilisation.
