FFuzkk Atlas of China
#93Official Top 100

Autobio Diagnostics

郑州安图生物工程股份有限公司

#93

IVD and diagnosticsMedical devices

Manufacturing profile

IVD and diagnostics
Medical devices

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. 1Reagent and calibrator preparation
  2. 2Analyser or test-system assembly
  3. 3Software algorithms and result calculation
  4. 4Analytical performance and stability
  5. 5Risk, software, EMC and cybersecurity evidence
  6. 6Design inputs and risk management
  7. 7Supplier and incoming controls
  8. 8Assembly and process validation
  9. 9Software, electrical safety, EMC and usability

Relevant FUZKK packages

Medical Devices Standards & Lifecycle QC SuiteMedical Device Software SuiteMedical Device Risk Management SuiteElectrical Safety & EMC SuiteUDI & Labeling Suite

Product/API utilities

Companion Diagnostic Report Checker

Lumex — instrumental QC

CE Inorganic Ions AnalyzerFluorat Nucleic Acids QuantifierLabWare CDS Bridge ConnectorAAS Glass Leachables Test

LabEx — laboratory QC

Assay & Impurity HPLC Quality CheckerMicrobial Enumeration (TAMC/TYMC) Quality CheckerBacterial Endotoxins LAL Quality CheckerStability Condition Monitoring Quality CheckerPackage Integrity & Leak Test Quality CheckerSterility Test Membrane Filtration Quality CheckerElemental Impurities ICP Quality Checker

Medical Devices — equipment and software lifecycle

Requirement Traceability CheckerSoftware Safety Class CheckerIntegration Test Coverage CheckerData Integrity Security CheckerCybersecurity Risk Assessment CheckerElectrical Safety Test Summary CheckerEMCTest Coverage CheckerCalibration Status CheckerSupplier Evaluation CheckerDesign Control Compliance CheckerRisk Management Report Completeness CheckerRisk Control Traceability 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