Page 3 - Maria Brochure IVDR
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Certification & Services

















                       Meeting ISO regulations can be challenging, but we are here to





                       help you. Sakura assists you with the following:

















































                                 Maintenance of                                                                   User training                                                                        Instrument                                                                          Material



                                       instruments                                                                                                                                                   qualification                                                                       vigilance








                      o Skills                                                                             o Official certificate                                                          o We ensure that                                                                o Local incident




                      o Optimal operation:                                                                 provided at the end                                                             our technology                                                                  assistance




                      maintenance service,                                                                 of the training                                                                 meets the quality





                      use of original                                                                      o 2 levels of training                                                          requirements of your




                      spare parts                                                                          (essential and                                                                  laboratory





                      o Intervention report                                                                advanced)




                      and compliance                                                                       o Post-training




                      checklist                                                                            evaluation










                                                                                                                                                                                             Fully IVDR compliant




                                                                                                                                                                                                  as of May 26th, 2022
























                                                                                                                                                                               You make the change, but we're there





                    Instrument documentation                                                                                                                                                                                              all the way.



                                    & consumables







                      o Safety Data Sheet,




                      operating manual,                                                                                                                                                                                                                                             Discover Bridge -





                      CE certificates                                                                                                                                                                                                                                               our new




                      o Certificate of batch                                                                                                                                                                                                                                        implementation




                      analysis                                                                                                                                                                                                                                                      consultancy





                      o Installation kit                                                                                                                                                                                                                                            service
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