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
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
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
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
Pre-compliance IEC 60601-1 Testing
We test your device, mitigating the cost of repeated compliance testing by evaluating potential non- compliances.
- 2-3 week typical lead time
- Documentation review
- Critical Component and Insulation Review
- Laboratory Testing
- HALT
Medical Device Biocompatibility Testing
We offer tests which evaluate cytotoxicity and biological risks within the chemical make-up of a medical device.
- 4-5 week typical lead time
- Biological Evaluation Plan & Report
- In Vitro & In Vivo methods
- Extractables & Leachables (E&L) Studies
- Also testing after cleaning, disinfection & sterilization
Reprocessing Validation for Class 1r Medical Devices
We test your medical device reprocessing procedures, as detailed in your IFU, validating the cleaning, disinfection and sterilisation cycles.
- 4-week typical lead time
- BS EN ISO 15883-5:2021
- BS EN ISO 15883-2:2009
- BS EN ISO 17665-1:2006
- 17025 UKAS accredited