In the European context, safety effectiveness and quality is ensured through the "Conformity Assessment" that is defined as "the method by which a manufacturer demonstrates that its device complies with the requirements of the European Medical Device Directive". The directive specifies different procedures according to the class of the device ranging from the simple Declaration of Conformity (Annex VII) for Class I devices to EC verification (Annex IV), Production quality assurance (Annex V), Product quality assurance (Annex VI) and Full quality assurance (Annex II). The Medical Device Directive specifies detailed procedures for Certification. In general terms, these procedures include tests and verifications that are to be contained in specific deliveries such as the risk management file, the technical file and the quality system deliveries. The risk management file is the first deliverable that conditions the following design and manufacturing steps. Risk management stage shall drive the product so that product risks are reduced at an acceptable level with respect to the benefits expected for the patients for the use of the device. The technical file contains all the documentation data and records supporting medical device certification. FDA technical file has similar content although organized in different structure. The Quality System deliverables usually includes procedures that ensure quality throughout all product life cycle. The same standard (ISO EN 13485) is usually applied for quality management systems in US and worldwide.