credit sleeve. Definition. Credit agreement between lender providing funds to another company co-guarantees the funds to increase the credit quality of the borrower. Credit sleeves are frequently created when a company's credit score drops and they lose access to more traditional methods of financing. Most Viewed.
CE Certification - Medical Device CE Marking. CE Marking (CE Mark) is a mandatory requirement for medical devices to market in the Europe. Medical Device category includes, medical equipments, medical softwares, medical & surgical disposables, etc... CE Marking (CE Mark) is recognized worldwide as a symbol of quality. It consists of CE logo and four digit identification number of the certifying notified body (if applicable). For a Medical Device manufacturer or Distributor, CE marking is the declaration that the product complies with all EU directives or EU regulations that apply to the medical device. CE marking does not implies that the product was made in the European Economic Area, but it states that the product is complying with the requirements of European Economic Area.
The following information is provided as general guidance to the Food and Drug Administration (FDA) regulation of medical devices. The Center for Devices and Radiological Health (CDRH) is the division of FDA responsible for medical device regulation.s the classification level increases, the risk to the patient and FDA regulatory control increase. Accessories to medical devices, devices used with a medical device to support use of the device, are considered the same classification as the medical device.