Shivmangla Health Care
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+91 9458550510
Kolkata, West Bengal, India
Zero-Compromise Standards

Clinical Precision & Uncompromising Quality Assurance

At Shivmangla Health Care, patient safety and clinical efficacy are foundational. Every pharmaceutical batch, diagnostic system, and surgical instrument undergoes multi-stage verification before dispatch or patient application.

100%
Batch Inspected & Certified
Inspection Workflow

Our 4-Stage Quality Assurance Pipeline

Rigorous testing mechanisms engineered to eliminate defect rates and exceed international healthcare benchmarks.

Stage 01
Raw Material & Component Audit

Spectroscopic and chemical analysis of all medical-grade alloys, polymers, and active pharmaceutical ingredients (APIs).

Stage 02
In-Line Production QC

Class 10,000 cleanroom manufacturing monitoring, ultrasonic cleaning inspection, and calibration testing.

Stage 03
Sterilization & Bio-Burden

Ethylene Oxide (ETO) and Gamma radiation sterilization validation with Class 5 chemical and biological indicator strips.

Stage 04
Batch Certificate of Analysis

Individual batch COA generation, barcode traceability, and tamper-evident hermetic packaging verification.

Quality Assurance Architecture
Accreditations & Compliance

Recognized Worldwide Certifications

Our enterprise operations comply with the highest national and international healthcare directives.

ISO 9001:2015
Quality Management Systems

Standardized organizational workflows, continuous quality improvement processes, and customer satisfaction tracking across wholesale logistics.

  • Documented traceability
  • Annual third-party audits
  • Systematic risk management
ISO 13485:2016
Medical Devices QMS

Specialized standard governing the lifecycle, distribution, storage, and traceability of medical devices and diagnostic machinery.

  • Cleanroom contamination controls
  • Sterile barrier validation
  • Post-market surveillance
CE Conformity
European Health & Safety

Conformity with European Union Medical Device Regulation (EU MDR 2017/745) for patient biocompatibility and electrical safety.

  • EN ISO 14971 Risk Analysis
  • Biocompatibility (ISO 10993)
  • IEC 60601-1 Electrical Safety
WHO-GMP Compliance
Good Manufacturing Practices

Guarantees that all wholesale pharmaceutical inventory is produced in adherence with World Health Organization GMP guidelines.

  • Validated cold-chain storage
  • Active stability profiling
  • Zero cross-contamination SOPs
CDSCO / Indian MDR
Medical Device Rules 2017

Full regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) for domestic supply and institutional distribution.

  • Registered Import / Wholesale Licences
  • Class A, B, C & D medical devices
  • Indian Pharmacopoeia standards
Bio-Medical Waste Compliance
State Pollution Board Norms

Strict clinical waste segregation and authorized safe disposal protocols at Shivmangla Dental Care operatories.

  • Color-coded bin segregation
  • Needle destruction & sharp safes
  • Certified CBMWTF disposal tie-ups
Institutional Audits

Require Official Audit Documents or COA?

Hospitals, government procurement cells, and research institutions can request full compliance portfolios, batch sterilization records, and audited Certificates of Analysis.

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