Detailsofmedicaldevicesoftwaredocumentsareasfollow:1.BasicinformationProductidentification,safetylevel,c***tructionandfunction,ha***arerelation,operationalenvironment,applicability,contraindication,historyofmarketentering2.Realizationprocess,developingsummarizing,riskmanagement,suitablespecification,verificationandconfirmation,defectmanagement,revisehistory,clinicalevaluation.3.Corealgorithm:Infact,thefirstregistrationformedicaldevicesoftwareshouldlistoutthenames,principles,usagesandstylesofallcorealgorithm.Theactualre-registrationshouldlistouttheonesthatarenewadded.Cannedsoftware:Forpartialmethodsofcannedsoftware,thedeclarationrequirementsofoutsourcing,finishedproductsandreservesoftwaremustbethesame,whichisexplainedindetailsintheformerchapter.Thedeclarationrequirementsformethodsofwhollycannedsoftwareareasfollow:1.Outsourcingsoftwareshouldprovideoutsourcingcontractandsoftwaredescribeddocuments2.Finishedsoftwareshouldprovideoutsourcingcontractandsoftwaredescribeddocuments.(contentwhichisnotsuitablemustexplain)eg:productsenterChinesemarketshouldprovidecopiesofproductregistrationandrelevantmaterials.3.Reservedsoftwareshouldprovidecopiesofproductregistrationandsoftwaredescribeddocuments.O***undacanprovidefullysoluti***ofmedicaldevicesfromproductdesign,clinicaltrail,producttesting,cleanworkshopdesignc***tructiontoenterprisesregistration(Productionlicense/productregistrationcertificate/businesslicenses),Internationalregistrationofproduct(EuropeanUnion,TheUnitedStates,Canada,Japan,Australia,Chinaandotherplaces).Sofar,we’vehelpedover1000nationalandinternationalenterprisestogetdifferentkindsofprofessionalcertification.O***undahassignedupwithmanyfamousnationalandinternationalmedicaldevicegroupsforlong-termagreementofoutsourcingauditsandc***ultingservice,)