Global Excellence in Medical Device Testing

Our Company

Medical Engineering Technologies has been supporting medical device manufacturers and developers since 1997.

Testing and validation of medical devices and their packaging is conducted at our ISO/IEC 17025 accredited laboratory facilities in Kent. This laboratory service is delivered by scientists and engineers, usually in support of CE marking and FDA submissions. This is done through a thorough understanding of international standards, risk analyses and robust Design Validation Testing (DVT) programmes.

Wherever you are in the world, our service will feel like we are neighbours. The best thing about working with MET is that we will be an extension of your project team. Here we think like medical device engineers.

Performance Testing

When developing medical devices within the framework of ISO 13485, design validation testing is essential. These tests must demonstrate that the device meets its product claims and is safe. This is the correlation of the design inputs and design outputs. The testing may range from simple bond strength tests to dosing accuracy at varying atmospheric conditions. MET’s lab will satisfy all your needs.

Chemical Analysis

For the demonstration of the biological safety of medical devices the emphasis is moving towards toxicity risk assessment and chemical analysis. Our analytical chemistry department conducts materials characterisation and extractable and leachables studies on devices and combination products, after fully reviewing the input materials and production circumstances. This delivers robust evidence that the toxicity end points have been met.

EMC

MET’s semi-anechoic chamber and full range of test equipment for radiated and conducted emission and immunity testing is at your disposal for EMC testing. Our engineers can develop test protocols and assess your device, along with your collaboration. We have a quick response time for testing and providing helpful advice.

The MET Story

Medical Engineering Technologies (MET) was started in 1997 by Mark Turner. The core of the business was selling the services of a large American medical device test facility. A few years later a colleague of Mark’s from his 10 years at Smiths Medical joined the company and they started the Market Vigilance section, handling failures and complaints for a leading medical device manufacturer and the growth of MET had begun.

Mark’s story began over 10 years earlier after studying chemistry at university and like most new graduates the path to his future career was not a straight one. 

Hi, I am Mark Turner and this is my story. Having studied chemistry at university, I found myself having interviews at paint factories and other small chemical producers. I wasn’t sure what I wanted to do with my life, but after the interviews I knew it wasn’t to be spent in a paint factory. Although I think this was more obvious to the interviewers than it was to me. Finding that first job (as it is for many new graduates) was hard, but I knew that I needed to work whilst I searched for my future direction. So, I sold hot dogs at a racecourse, I was a burger chef and I sold ice creams on the beach. Then I made the decision to continue my studies in a slightly different field of electronics and medicinal chemistry. My first career position was designing printed circuit boards for a small scientific instrument company. From this work came a complete change in direction. I moved on to my introduction to medical devices. I secured a new job as a perfusionist (operating the blood pumps and oxygenators during open heart surgery). Is this the way it works for other people? Your career path is decided by the first real job where you can see a pathway ahead?

From working in a hospital, I moved to Smiths Medical as a designer/project manager in the development of oxygenators, anaesthetics and wound drainage equipment. After progressing in this role for 10 years, I decided to pursue an independent path based on the integration of the medical device industry across the globe.

MET was set up to liaise between service providers with device developers across borders. From the original concept, our own laboratory has grown. Initially, we specialised in packaging validation and the decontamination of used devices for post market inspection. During the intervening years (since 1997), the company has grown into a leading supplier of device validation across a very broad range of analytical techniques.

Working with MET

We at Medical Engineering Technologies we have systematised our work programmes to maximise efficiency and accuracy, and most importantly to comprehensively deliver the information required by you, the client.

At the time of quoting we will review ISO standards along with national guidance(s), to rapidly plan a method of testing for the medical device or delivery system (often conducting a risk analysis). The next stage in the process is the development of a protocol with the client. We have many standard procedures which can reduce the required time to hours, particularly in the case of packaging validation and wound dressing test protocols.

Your purchase order is the contract for the work to progress. Once this is in place, we will deliver the protocol for your approval. If the samples are at MET testing normally commences within a few days of the method approval. A project plan is issued on receipt of the samples and a draft report will be issued following testing to allow the client to verify batch numbers and product descriptions. Regular updates are provided for extended projects. The final report is your gateway to regulatory approval.

 

 

Medical Device Testing