Proposals are hereby invited for the following: Provision of CE Marking of the Umbi flow (continuous-wave fetal ultrasound) Medical Device, EU Class II-a to the CSIR. Scope of Work: The CSIR aims to obtain CE marking for the Umbiflow (EU Class IIa) medical device as soon as possible and the bidder’s ability to expedite the CE Marking process is therefore of importance. CE marking is mandatory for Umbiflow’s introduction into the South African market as per regulatory requirements. Umbiflow has been developed by the CSIR’s Industrial Sensors Impact Area within the Manufacturing Cluster in collaboration with the South African Medical Research Council and the team holds current certification in ISO 9001 and ISO 13485 along with a SAHPRA Manufacturing License for Umbiflow for clinical trial application. In compliance with regulatory requirements, the Cluster aims to obtain CE marking for the Umbiflow medical device (EU Class IIa). The Umbiflow device has already passed EMC/EMI and ultrasonic radiation emission tests at accredited labs (in Canada and UK respectively). CE marking is mandatory for Umbiflow’s introduction into the South African market as per regulatory requirements. (Oferta №90788215es)