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Why Can We Always Ensure Excellent Quality

Quality Control

Miconveyusesstrictqualityprocesstoensuretheperformanceanddurabilityofeachsurgicalequipment.Andweequipaqualifiedteamto

inspectqualitymanagement,specificallythetechniquesandactivitiestomeetthequalityrequirements.

MICONVEY TECHNOLOGIES CO., LTD

1.Establishment of QualityProcess

  • Establishmentofannualvalidationprocess;
  • Improvedcomplaintprocess;
  • NCRsystem;
  • Adverseeventmonitoringsystemdocumentation.

2.Inspection Activities

  • Establishmentofinitialinspection,in-processinspection,finalinspection,andoutgoinginspection;
  • 100%inspectionofkeyprocesses;
  • Monthlyassessmentofinspectionskill;
  • Annualexternalcalibrationofmeasuringinstruments

3.Customer-oriented Quality Improvement

  • Establishmentofcustomercomplaintlaboratory;
  • Establishmentofcustomercomplaintinvestigation;
  • UpdateCTQproductionlinecontrol
  • Standardsbasedoncustomerrequirements

4.Production Quality Improvement

  • EstablishmentofCTQKeyQualityControlPointsfortheProductionProcessImprovementofUltrasonicScalpel,Stapler,andSponge;
  • EnhancementofMicrobialInspection
  • CapabilityandDeterminationofEODetectionMethods.

Testing Facilities

MICONVEY TECHNOLOGIES CO., LTDMICONVEY TECHNOLOGIES CO., LTDMICONVEY TECHNOLOGIES CO., LTD

Assemble Line Inspection

MICONVEY TECHNOLOGIES CO., LTDMICONVEY TECHNOLOGIES CO., LTDMICONVEY TECHNOLOGIES CO., LTD

Quality Control

MICONVEY TECHNOLOGIES CO., LTDMICONVEY TECHNOLOGIES CO., LTDMICONVEY TECHNOLOGIES CO., LTDMICONVEY TECHNOLOGIES CO., LTD

Certification

MICONVEY TECHNOLOGIES CO., LTD Certifications
Standard: CE
Number: HD601249740001
Issue Date: 2018-02-07
Expiry Date: 2022-02-07
Scope/Range: Surgical instrument
Issued By: TUV Rheinland
MICONVEY TECHNOLOGIES CO., LTD Certifications
Standard: ISO 13485
Number: SX601459830001
Issue Date: 2020-02-21
Expiry Date: 2023-01-24
Scope/Range: Surgical instrument
Issued By: TUV Rheinland
MICONVEY TECHNOLOGIES CO., LTD Certifications
Standard: FDA
Number: K162947
Issue Date: 2017-01-30
Scope/Range: Surgical instrument
MICONVEY TECHNOLOGIES CO., LTD Certifications
Standard: IEC 60601
Number: 50099634001
Issue Date: 2017-09-04
Scope/Range: Generator
Issued By: TUV Rheinland
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