Medical And Combination Device Testing News

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Aug 10, 2016 |
MET News,  |
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When is GLP Required?

First off what is GLP?

Good Laboratory Practice was not initially developed in the USA, but is defined in 21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies. It is a laboratory and quality control system intended to ensure that all phases of studies are completed accurately. Processes include: planning, protocol agreement, execution, monitoring, recording, reporting and archiving, all of these aspects should all be delivered in a consistent and accurate fashion. GLP is primarily concerned with establishing the safety of industrial chemicals, agro and food chemicals and cosmetics.

Is GLP Required for Medical Device Testing?

GLP applies to non-clinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals) with respect to man, animals and the environment.

EC Directives do not require the implementation of GLP for toxicity assessments of medical devices, whereas FDA regulations do.

Physical testing is not generally conducted to GLP even when it is safety testing. It should be conducted in a laboratory with a good quality system such as ISO 17025, but many of the components of GLP such as animal husbandry are not appropriate. The application of a Quality Management System along with prior agreement of protocols and good quality assurance will give regulatory authorities confidence in the evidence of product performance produced. This will in turn allow an accurate risk assessment to be made.

What Does MET Provide

Studies conducted in our laboratory are all subject to our strict quality control. Our QMS is independently audited and ILAC recognised under ISO 17025. We agree test procedures and protocols with clients in advance and follow horizontal standards whenever possible. For devices with no or outdated ISO or ASTM standards we can quickly develop definitive test protocols following a risk analysis.