Medical device FDA certification how to do, FDA cost is how much

In accordance with the 93/42/EEC Directive, first of all, the device should be classified, if it is a class I device, generally find an organization to test and write a declaration of conformity, and find a European generation on the line. II class above the category, it is recommended that in accordance with the Directive Appendix 2 of the authentication method, to find a certification body with a NB number, according to the requirements for the establishment of the quality system, technical documentation and to do the type test, the audit can be passed to obtain the CE certificate. NB organization must choose the EU countries. For example, TUV SUD South Germany, BSI British Standard, Czech ITC and so on.