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    Biocompatibility 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. Read more on Biocompatibility Testing...

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    Efficacy Testing

    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.. Read more on Efficacy Testing...

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    Materials Testing

    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.... Read more on Materials Testing...

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    Customer Returns

    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.. Read more on Customer Returns...

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    Medical Device Testing...

    MET has expertise in testing to a wide range of standards, here are just a few of them Devices. ASTM F2394 Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System. ASTM F2081 Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents. ASTM F2477 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents1. ASTM F2743 - 11 Standard Guide for Coating Inspection and Acute Particulate Characterization.... Read more on Medical Device Testing Standards...

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    About MET

    MET has successfully delivered design validation services in: Africa, Asia, Australasia, Europe and the USA. During 2014 we have effectively supported clients from 16 countries. Our process begins with understanding your device and carrying out a risk analysis. This information is combined with the ‘product claims’ to develop a design validation testing plan which is then efficiently implemented providing the data to support your product launch. Read more on device testing. Read more on About MET...

We Know Medical Devices

MET is supporting medical device companies across the globe. Our key engineers were involved in  developing medical devices for blue chip anaesthetics manufacturers. As a result, we know about medical devices, how they work, and their regulatory needs. 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 Global, Excellence in Medical Device  Testing programme includes:

 

Performance Testing

Whether your objective is CE marking, a submission to the FDA, benchmarking or marketing support data, we are able to assist you. Our ISO 17025 certified laboratory is used to dealing with many different applications of medical devices, and with drug delivery products from auto-injectors to sprays and creams. With our extensive background in the medical device industry, we can even participate in your Risk Analysis and process FMEA (Failure Mode and Effects Analysis) to ensure that the correct data is available to support your product claims....   Laboratory testing read more...

 

Materials Testing

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...

 

Biocompatibility 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 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 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 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...

 

 Excellence in medical device testing.