Flash Programmer — Production Workstation

The Flash Programmer, an electrical device intended for use at a production workstation within a medical manufacturing environment, was provided by the client for conformity assessment and preparation of the documentation required to issue the Declaration of Conformity. The scope of work included device classification, identification of applicable EU directives and harmonised standards, and conformity assessment against the identified requirements. The required EMC test scope was defined, the tests were performed and a corresponding test report was prepared. Electrical safety testing was also carried out in accordance with the requirements of the applicable safety standards. Based on the completed assessment, the technical documentation and documentation required for the Declaration of Conformity were prepared in accordance with the applicable directive requirements. The Declaration of Conformity was prepared for signature by the person responsible within the client’s organisational structure.