Quality & Certifications
ISO 13485:2016 Certified | CDSCO Form MD-42 Licensed | ISO 9001:2015 QMS | CE Compliant
Registration Certificate to Sell, Stock, Exhibit or Distribute Medical Devices
National & International Compliance Accreditations
Click any credential to inspect attested documentation
ISO 13485:2016 Certified
Medical Devices — Quality Management Systems requirements for clinical regulatory purposes.
CDSCO Form MD-42
Central registration to stock, sell and distribute Class A–D medical devices.
ISO 9001:2015 QMS
Quality management systems for healthcare supply chain, metrology calibration, and service delivery.
CE European Conformity
Certified conformity with European medical health, safety, and performance standards.
WHO-GMP & WHO-GDP
Good Manufacturing & Distribution Practice for medical goods and cold-chain integrity.
GeM & EEPC India Exporter
Government e-Marketplace registered supplier & Ministry of Commerce engineering exporter.
Equipment Category Compliance & Standards Matrix
Rigorous medical safety testing per equipment domain
4-Step Pre-Dispatch Biomedical Testing Protocol
Every unit undergoes strict bench calibration before delivery to hospitals or clinics
Electrical Safety Testing
Ground bond resistance < 0.1Ω and chassis leakage currents tested under single-fault conditions.
Flow & Pressure Metrology
Flow rates, airway pressure triggers, and oxygen purity calibrated against NABL-traceable standards.
Patient Signal Simulation
Simulated arrhythmia, blood pressure curves, and pulse oximetry optical waveforms verified across channels.
72h Burn-in & Sanitization
Continuous load testing followed by medical cleanroom UV-C sterilization and sealed packaging.
Verify Official Registration & Batch Quality Clearance
Enter central license or batch code to retrieve official records
Downloadable Hospital Tender & Compliance Dossiers
Pre-compiled for hospital procurement committees, GeM tenders, and NABH clinical audits
Hospital Procurement Master Dossier
Form MD-42, CE compliance documentation, GST clearance, and 24/7 AMC warranty templates.
CDSCO Form MD-42 Statutory Registration
Attested copy of registration UP/GHA/MD42/2026/000142, warehouse layout, and technical person resume.
Biomedical Metrology & Quality Manual
Executive summary of SOPs, electrical safety testing, and pre-dispatch calibration tolerances.
Trusted by India's Foremost Hospitals, Defence & Diagnostic Networks
Supplying CDSCO Form MD-42 validated medical devices, ICU equipment, and emergency rentals nationwide.