Uncompromising Quality Standards

Precision, Reliability, and Excellence in Every Instrument We Manufacture

Our Certifications & Standards

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ISO 13485:2016 Certified

Medical Devices Quality Management System

Certificate No: RBSC-ISO-2024-001
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CE Mark Certified

Compliant with European Medical Device Regulations

CE 0483
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FDA Registered

US Food and Drug Administration Compliance

Reg. No: 3014567890
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SIMAP Registered

Surgical Instruments Manufacturers Association of Pakistan

Reg. No: 3254781
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PMDA Registered

Pharmaceuticals and Medical Devices Agency

Reg. No: 3014567890
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WHO-GMP Compliant

World Health Organization Good Manufacturing Practices

GMP/PAK/24/187

Our 7-Stage Quality Assurance Process

1

Raw Material Inspection

Every batch undergoes spectrometric analysis to verify AISI 420/316L stainless steel composition

  • Material Certification Verification
  • Chemical Composition Testing
  • Metallurgical Structure Analysis
2

Precision Forging

Computer-controlled drop forging ensures dimensional accuracy and grain structure integrity

  • CNC-Controlled Forging Process
  • Grain Flow Optimization
  • Dimensional Precision Control
3

Heat Treatment

Precise tempering and hardening cycles for optimal hardness (HRC 48-52) and flexibility

  • Controlled Atmosphere Hardening
  • Triple Tempering Process
  • Hardness Verification Testing
4

Surface Finishing

Mirror polishing and satin finishing for corrosion resistance and smooth operation

  • Electropolishing for Mirror Finish
  • Satin Finishing for Reduced Glare
  • Surface Roughness Testing
5

Functional Testing

Every instrument undergoes operational testing to ensure proper function and ergonomics

  • Cutting Edge Sharpness Testing
  • Joint Movement Smoothness
  • Locking Mechanism Verification
6

Sterilization Validation

Instruments tested for autoclave compatibility and sterilization effectiveness

  • Autoclave Cycle Testing (134°C)
  • Chemical Sterilization Compatibility
  • Material Integrity Post-Sterilization
7

Final Quality Control

17-point final inspection before packaging and certification

  • Visual Inspection under 10x Magnification
  • Dimensional Accuracy Check
  • Final Functional Testing

Material Excellence

German Stainless Steel AISI 420

Hardness: HRC 48-52
Corrosion Resistance: Excellent
Tensile Strength: 850-1000 MPa
Composition: C 0.35%, Cr 13.5%

Premium surgical-grade steel for superior edge retention and durability in demanding surgical environments

Medical Grade Titanium

Hardness: HRC 36-40
Biocompatibility: Excellent
Weight: 45% Lighter than Steel
MRI Compatibility: Non-Magnetic

For MRI-compatible, lightweight applications requiring superior biocompatibility and corrosion resistance

Advanced Testing Facilities

Metallurgical Laboratory

  • Spectrometric Chemical Analysis
  • Microstructure Examination
  • Hardness Testing (Rockwell/Vickers)
  • Salt Spray Corrosion Testing
  • Grain Size Analysis

Dimensional Control

  • Coordinate Measuring Machine (CMM)
  • Optical Comparators
  • Laser Micrometers
  • Surface Roughness Testers
  • Profile Projectors

Functional Testing

  • Cutting Edge Sharpness Testers
  • Cyclic Fatigue Testing
  • Torque and Force Measurement
  • Ergonomics Evaluation
  • Sterilization Cycle Testing

Our Quality Performance

99.7%
Quality Acceptance Rate

Consistently high quality across all production batches

0.02%
Customer Return Rate

Industry-leading low return rate for quality issues

100%
Traceability Guaranteed

Complete batch tracking from raw material to final product

25+
Quality Checkpoints

Comprehensive inspection throughout manufacturing

Manufacturing Excellence

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CNC Precision Machining

Computer-controlled machining centers ensuring micron-level precision and repeatability in every instrument

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Clean Room Assembly

Class 100,000 clean rooms for critical assembly processes, maintaining sterile manufacturing conditions

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Laser Marking

Permanent laser identification for complete traceability and anti-counterfeiting measures

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Statistical Process Control

Real-time monitoring and control of manufacturing processes using advanced SPC systems

Quality Guarantee & Warranty

🔧 24-Month Warranty

Comprehensive warranty against manufacturing defects and material flaws

⚡ Rapid Response

48-hour response time for quality concerns and technical support

🔄 Replacement Policy

Immediate replacement for verified quality issues, no questions asked

📞 Technical Support

Dedicated technical team for instrument care, maintenance, and sterilization guidance

Quality Documentation

Download our quality certificates and documentation

Quality Manual

Complete quality management system documentation and procedures

📥 Download PDF

Material Certificates

Raw material analysis and certification documents for traceability

📥 Download PDF

Sterilization Guide

Comprehensive instrument care, handling and sterilization instructions

📥 Download PDF

Committed to Surgical Excellence

Every instrument we manufacture carries our promise of quality, precision, and reliability

Request Quality Certificates View Our Products