FFuzkk Atlas of China
#21Official Top 100

Wego Group

威高集团有限公司

#21

Medical devicesSterile products

Manufacturing profile

Medical devices
Sterile products

Selection basis

The company is included in the official 2024 ranking of the 100 largest Chinese pharmaceutical-industry enterprises by main-business revenue.

The FUZKK fit shows potential applicability of existing utilities. It does not claim actual use of FUZKK, specific installed equipment models or a product not confirmed by the public company profile.

Representative manufacturing and QC chain

  1. 1Design inputs and risk management
  2. 2Supplier and incoming controls
  3. 3Assembly and process validation
  4. 4Software, electrical safety, EMC and usability
  5. 5Sterilisation, packaging and UDI evidence
  6. 6WFI, clean steam and cleanroom HVAC
  7. 7Solution preparation and bioburden control
  8. 8Sterile filtration
  9. 9Isolator/RABS filling or lyophilisation

Relevant FUZKK packages

Medical Devices Standards & Lifecycle QC SuiteMedical Device Risk Management SuiteMedical Device Software SuiteElectrical Safety & EMC SuiteUDI & Labeling SuiteLabEx QC SuiteSterile Medical Devices SuiteChina: national essential medicines QC package

Product/API utilities

Water For Injections Quality CheckerFill Volume & Container Closure CheckerCompanion Diagnostic Report Checker

Lumex — instrumental QC

AAS Glass Leachables TestCE Inorganic Ions AnalyzerLabWare CDS Bridge Connector

LabEx — laboratory QC

Sterility Test Membrane Filtration Quality CheckerBacterial Endotoxins LAL Quality CheckerParticle Count Injection USP <788> Quality CheckerFilter Integrity Test Quality CheckerPackage Integrity & Leak Test Quality CheckerOsmolality Quality CheckerEnvironmental Monitoring Cleanroom Quality CheckerMicrobial Enumeration (TAMC/TYMC) Quality CheckerElemental Impurities ICP Quality Checker

Medical Devices — equipment and software lifecycle

Design Control Compliance CheckerRisk Management Report Completeness CheckerRisk Control Traceability CheckerRequirement Traceability CheckerSoftware Safety Class CheckerData Integrity Security CheckerCybersecurity Risk Assessment CheckerElectrical Safety Test Summary CheckerEMCTest Coverage CheckerUDIData Completeness CheckerPackaging Integrity CheckerSterility Assurance Level Checker

Suggested first pilot

  1. Confirm one real product, method or recurring QC review.
  2. Record the instrument, export format and current specification.
  3. Select 3–7 utilities from the map above.
  4. Run a PASS/FAIL sample and agree the expected output.
  5. After user validation, expand the scope.

Mapping boundary

The FUZKK fit shows potential applicability of existing utilities. It does not claim actual use of FUZKK, specific installed equipment models or a product not confirmed by the public company profile.

Methodology