Examples of Medical Device Directive in a sentence
The medical equipment of USA must comply with 510(K) FDA (Food & Drug Administration), in case of Europe MDD (Medical Device Directive) and for Japan MHLW (Ministry of Health, Labour& Welfare) for specific quoted model.
The member countries of the European Union have adopted the European Medical Device Directive, which creates a single set of medical device regulations for products marketed in all member countries.
Manufacturing Company should have Valid European CE certificate as per Medical Device Directive 93 / 42 / EEC or US FDA Certificate should be submitted with the offer.
To obtain authorization to affix the CE mark to a product, a recognized European Notified Body must assess a manufacturer’s quality systems and the product’s conformity to the requirements of the Medical Device Directive.
Compliance with the Medical Device Directive and certification to a quality system enable the manufacturer to place a CE mark on its products.