Quality Made Easy was founded by Lydia Kluver in 2010.
After more than 30 years of experience, working for several employers, she decided to set up a company of her own.
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An (IVD) medical device can only be sold in Europe with a CE mark. By placing the CE mark on a product, the manufacturer declares that the product complies with the applicable European regulation for medical devices (2017/745) or IVD medical devices (2017/746)
Only notified bodies for medical devices can issue product specific CE certificates and declarations of conformity for your class I (sterile or measuring function), class IIa, class IIb or class III product. Class I products that are not sterile or do not have a measuring function do not require a certificate from a notified body. These products are certified by the manufacturer himself.
With the introduction of the new regulations 2017/746 only notified bodies for IVD medical devices can issue product specific CE certificates and declarations of conformity for your class A (sterile or measuring function), class B, class C or class D product. Class A products that are not sterile or have no measurement function do not require a certificate from a notified body. These products are certified by the manufacturer himself.
European regulations require that a comprehensive medical device file is compiled for each risk class of (IVD) medical devices which (except for class I medical devices and class A IVD medical devices) must be reviewed and approved by the notified body before the issue of a CE certificate can realised.
QME can help you in determining the risk class of your product, the choice of the CE marking route and in compiling of the complete (IVD) medical device file.