IngenesTM provides testing services for electromagnetic compatibility (EMC) to IEC/EN 60601-1-2 including the recently published updates for the 4th edition that is used to show compliance to the Medical Device Directive 93/42/EEC.
The updated EMC testing procedures include test levels are formal requirements for manufacturers to not only include risk assessment, but also detailed testing parameters to be used for the compliance process. This would ensure that the areas identified in the risk assessment are clearly defined and addressed. This process helps meet the essential performance requirements for the EU Medical Device Directive, and submissions to U.S FDA, and other global compliance requirements.
IngenesTM testing process will ensure that your product meet all requirements of the applicable standards for Medical Device Directive that effectively allows you to market your product to bear the CE Mark in the EU and meet the FDA requirements in the US, and access other global markets.
To find out more about the changes in IEC/EN 60601-1-2: 4th Edition, please contact us or request a quote.
Please contact us for further information about our Electromagnetic compatibility(EMC) testing services. We may be able to assist you to get this done for you at a significantly lower cost.
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