The Medical Device Directives: A Manufacturers' Handbook

By Gordon R. Higson, founding chairman, ISO TC 210, Quality management and corresponding general aspects for medical devices. Help for manufacturers who need to understand how to comply with European regulations. It analyzes and interprets the legal texts of the directives, which went into effect in June 1993, and determines how they apply to medical devices. The book covers topics crucial to the directives, including essential requirements and standards, conformity assessment, clinical evaluation and custom-made devices, labeling and language, and transposition of the Medical Devices Directives into national law. Also, the handbook contains the latest versions of key documents, such as the MEDDEV Documents issued by the European Commission. See more