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Regulatory Environment

 

With 50+ years of experience in the development and manufacturing of in vitro diagnostic (IVD) instrumentation, LRE Medical has a thorough understanding of the regulatory environment and has integrated its processes seamlessly with all known requirements.

As such, LRE Medical’s products are designed and manufactured for:

  • Safety
  • Performance
  • Reliability (e.g., hardware, software, processes)
  • Manufacturability
  • Electromagnetic compatibility (EMC)
  • Testability
  • Usability

LRE Medical designs, manufacturers, validates, verifies and complies with the following medical and agency standards, certifications, and registration requirements:

Certifications

 

Registrations

 

Medical Device Standards

 

  • 98/79/EC (in vitro Diagnostic Medical Devices
  • 93/42/EEC (Medical Devices)
  • 2004/108/EC (Electromagnetic Compatibility)
  • 2006/95/EC (Low Voltage)
  • 89/392/EC (Product Safety)
  • 1999/5/EC (R & TTE)
  • 90/385/EEC (Serious Adverse Event Reporting)
  • ISO 14971:2007 (Application of Risk Management to Medical Devices)
  • IEC 60601 (safety and effectiveness of medical electrical equipment)
  • IEC 60812 (Failure Mode and Effects Analysis and Failure Mode, Effects and Criticality Analysis)
  • IEC/UL 61010-1 (Laboratory in vitro Diagnostic Electrical Equipment, Laboratory Electrical Equipment for Use in Health Care Application
  • IEC/UL 60950-1 (Information Technology Equipment – Safety)
  • IEC/UL 60601-1 (Medical Electrical Equipment, Part 1, General Requirements for Safety)
  • EN/IEC 62304 (Medical Device Software - Software Life Cycle Processes)
  • EN/IEC 62366 (Medical Devices - Application of Usability Engineering to Medical Devices)
  • 21 CFR, Part 801 – 866 (e.g., Labeling, in vitro Diagnostic Products for Human Use, Quality System Regulation, Clinical Chemistry and Clinical Toxicology Devices, Hematology and Pathology Devices, Immunology and Microbiology Devices, etc.)

Audits

 

  • FDA
  • TUV
  • UL - Quarterly Plant Inspections

 

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