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.

We build our relationship with you based on honest and open communication

Understanding your needs is our number one priority. We take the time to listed to you, as we understand the impact we have in the broad market context. We earn your trust by being reliable – we get there by maintaining clear and constant communication.

We have developed a framework that keeps you in control of your timelines – we've pioneered a faster, agile approach to research and testing.

In the current regulatory climate, maintaining the status quo is simply not good enough. Our team will provide you with the information that is relevant to you and suits your needs. Running a consultancy business is hard work – we are here to help you grow.

Get in touch today to discover how we work with you.

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.

Dental instrument IFU validation in under 4 weeks – Case study

Learn how Test Labs team successfully completed dental instrument IFU validation study in under 4 weeks

A Guide to UKAS Accreditation: Everything You Need to Know

UKAS Accreditation - ‘Accreditation’ and ‘certification’ often get used interchangeably, however, they are distinctly different

Dental Product Material Compatibility Testing – Case study

Medical device safety testing includes material compatibility studies with wide range of quantitative measurements

FDA Validation Requirements for Reusable Medical Devices: 21 CFR 801.5

FDA Validation Requirements for Reusable Medical Devices: guidance on the requirements and criteria for validation data

Technical file requirements for Class Ir: Everything you need to know

MDR requires a clear, organized, searchable, and unambiguous technical file presentation

A Guide to Good Laboratory Practice (GLP): Everything You Need to Know

GLP is a defined set of principles to be implemented in a QMS by an organisation completing non-clinical studies

Medical Device Safety Testing – MDR focus on material compatibility

The EU Regulation 2017/745 (MDR) heavily focuses on the safety and performance of a medical device for the lifetime of the product

Post-Market Surveillance (PMS): Everything You Need to Know

The purpose of a PMS system is to identify risks, not previously known, and opportunities for improvement in a timely fashion