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Medical Device Testing
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 10993:2003 Biological evaluation of medical devices. This standard defines devices in terms of their invasiveness and duration of patient contact and subsequently determines what level of safety testing manufacturers need to successfully complete prior to putting their... Safety testing read more...
Whether your objective is CE marking, a submission to the FDA, benchmarking or marketing-support data, we are able to assist you. Our ISO 9001-2008 certified laboratory is run by engineers with a minimum of 15 years experience in the medical device industry, who can even participate in your Risk Analysis and process FMEA (Failure Mode and Effects Analysis) to ensure that correct data is available to support your product claims. 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 transfer of leachable materials from packaging and labelling. Material characteristion testing read more...
Are product complaints diverting man power and consuming resources you'd 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 devices vigilance system" stipulating that "any manufacturer selling on the European market should make sure that their vigilance... Complaints analysis read more...
Medical Device Testing Standards
MET has expertise in testing to a wide range of standards, here are just a few of them... Medical Device Testing Standards read more...