FFuzkk Atlas of China
#62Official Top 100

Lepu Medical

乐普（北京）医疗器械股份有限公司

#62

Medical devicesIVD and diagnostics

Manufacturing profile

Medical devices
IVD and diagnostics

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. 6Reagent and calibrator preparation
  7. 7Analyser or test-system assembly
  8. 8Software algorithms and result calculation
  9. 9Analytical performance and stability

Relevant FUZKK packages

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

Product/API utilities

Companion Diagnostic Report Checker

Lumex — instrumental QC

AAS Glass Leachables TestCE Inorganic Ions AnalyzerLabWare CDS Bridge ConnectorFluorat Nucleic Acids Quantifier

LabEx — laboratory QC

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