Meeting regulatory requirements in the varied world of medical devices requires deft project management. This can be a difficult and complex job. You have to balance the needs of a lot of different parties whilst staying within budget and holding to tight deadlines. The clinical needs and safety of the device are paramount and must be demonstrated. Partnering with Medical Engineering Technologies will ensure that his part of your project runs efficiently and smoothly. Our technicians are frequently devising sophisticated protocols under pressure and they are fully resourced to ensure rapid delivery of test work. We cannot guarantee what the results will be or shorten the dwell time in a test, but we can ensure the accuracy and efficiency.
Partner with MET for your medical device testing and we promise:
- Rapid and competitive quotations
- Rapid project commencement
- Rapid access to equipment
- Efficient delivery and reporting.
We work to ISO 17025 and GMP. Once a contract is in place (purchase order, statement of work or technical agreement) we will respond with a protocol for your approval or comment within days.
Medical device testing is the process of demonstrating that the device will reliably and safely perform in use. In new product development, extensive Design Validation Testing is applied. This includes performance testing, toxicity and chemical analysis, and sometimes human factors or even clinical testing. Ongoing quality assurance testing is generally more limited. This will usually include dimensional checks, some functional tests and packaging verification.
We Know Medical Devices
MET is supporting medical device companies across the globe, having conducted thousands of projects. Our key engineers have previously been involved in developing medical devices for blue chip anaesthetics manufacturers. As a result, we know about medical devices, how they work, and their regulatory requirements. Most importantly, we know how to apply risk analysis to your product and apply the result to deliver a fast, cost-effective design validation and verification service.
You can benefit from this inside knowledge. We have testing experience with all classes of device and in many applications.
Our laboratory has vast experience dealing with a wide variety of medical devices, from surface contact to permanent implants, and with drug delivery products from auto-injectors to sprays and creams. Laboratory testing read more...
Material characterisation has many applications in medical device development and production. It is the chemical analysis of materials to identify a ’finger print’. This information is then used to minimise toxicological testing of new designs and for production and design changes. Chemical identification should also be applied to incoming raw materials and on lot to lot production. MET has a wide range of chemical analysis equipment at its disposal for the knowledgeable application of characterisation. The methods are equally applicable to studying cleaning residues and the transfer of leachable materials from packaging and labelling... Material characterisation testing read more...
Medical devices require varying degrees of biocompatibility testing, according to their classification. The main source of guidance on the essential requirements for biological safety is ISO 10993 - Biological evaluation of medical devices. This standard defines devices in terms of their invasiveness and the duration of patient contact, which subsequently determines what level of safety testing manufacturers need to successfully complete prior to putting their device on the market. .... Safety testing read more...
First Line QA
Are product complaints diverting manpower and consuming resources you would rather spend elsewhere? Customer returns are an inevitable part of the business, but they need not be an integral part of yours! Our unique First Line QA service makes it easy to comply with the EU MEDDEV 2.12-1 Rev 5 "Guidelines on a medical device vigilance system" stipulating that "any manufacturer selling on the European market should make sure that their vigilance... . Complaints analysis read more...