[email protected] +92-320-6688665 Defence Road, Sialkot 51310, Pakistan
ISO 13485:2016 · CE Marked · FDA Registered Exporting to 45+ Countries
Certified OEM / ODM Manufacturing

Custom OEM Manufacturing

Precision-engineered contract manufacturing, private labeling, laser branding, and custom surgical instrument solutions for medical device importers and global brand owners.

Production Excellence

End-to-End OEM & ODM Capabilities

Transforming complex clinical requirements into compliant, market-ready surgical instruments manufactured under an ISO 13485 quality system in Sialkot, Pakistan.

Custom Branding & Marking

Ensure full brand recognition and regulatory compliance with advanced surface marking executed in-house prior to final passivation.

  • Fiber laser logo & brand name marking
  • Catalogue reference & lot code engraving
  • GS1-compliant UDI barcode marking
  • Chemical etching for micro-instruments

Private Label Solutions

Complete private-label manufacturing programmes tailored for medical supply distributors, hospital vendors, and OEM brands.

  • Full white-label contract production
  • Custom blister, pouch & box packaging
  • Tray-mounted procedure set configurations
  • Regulatory technical file documentation support

Bespoke ODM Engineering

Collaborative instrument engineering to modify existing patterns or create bespoke tools from technical drawings or physical samples.

  • 2D/3D CAD design & forging die fabrication
  • Working length, tip angle & curvature changes
  • Custom jaw serration & Tungsten Carbide inserts
  • Rapid pre-production prototyping (7–10 days)
Metallurgical Rigour

Certified Medical-Grade Raw Materials

Long-term surgical performance begins with metallurgical purity. We source certified stainless steel and titanium alloys accompanied by full heat lot certificates.

German Stainless Steel

Martensitic AISI 420 and 410 stainless steel selected for exceptional tensile strength, hardness, and corrosion resistance following thermal treatment.

  • Hardness Rating: 48 – 54 HRC
  • Optimal edge retention for scissors & rongeurs
  • Passivated to withstand 134°C autoclave cycles

Japanese Stainless Steel

High-carbon Japanese steel grades engineered for specialized cutting tools requiring ultra-sharp micro-edges and minimal blade deflection.

  • Hardness Rating: 54 – 58 HRC
  • Micro-serrated precision cutting edges
  • Superior wear resistance in intensive procedures

Titanium Grade 5 (Ti-6Al-4V)

Biocompatible, non-magnetic titanium alloy specifically utilized for lightweight microsurgical forceps and non-stick electrosurgical bipolar tips.

  • 40% lighter than surgical steel
  • Fully MRI compatible & anti-corrosive
  • Reduced surgical hand fatigue during neurosurgery
Structured Execution

6-Stage OEM Production Process

From initial design evaluation to final export containerization, every production step is controlled by documented ISO 13485 quality procedures.

01

Design & Engineering Review

Our technical team reviews your technical drawings, samples, or specifications to perform feasibility analysis and establish tolerance criteria.

02

Tooling & Prototyping

Precision forging dies and CNC tooling are produced to build pre-production physical samples for client evaluation and functional testing.

03

Validation & Approval

Physical prototypes, accompanied by dimensional inspection reports and material test certificates, are submitted for formal customer sign-off.

04

Series Forging & CNC Machining

Hot closed-die drop forging followed by precision 5-axis CNC milling to achieve exact joint alignments and ratchet engagements.

05

Heat Treatment & Passivation

Vacuum hardening and tempering to specified HRC values, followed by ultrasonic chemical cleaning and acid passivation (ASTM F895/F1089).

06

AQL Quality Control & Release

100% visual and functional inspection, fiber laser branding, custom packaging, and release with full batch traceability records.

Commercial Terms

Minimum Order Quantities & Timelines

Flexible contract manufacturing terms engineered to help medical device importers launch and scale their private-label product lines.

Manufacturing Program Minimum Order Quantity (MOQ) Pre-Production Sample Production Lead Time
Catalogue OEM (Custom Laser Branding) 50 pieces / reference 5 – 7 working days 15 – 25 working days
Custom Private Label Packaging & Sets 50 complete sets / trays 7 – 10 working days 20 – 30 working days
Modified Pattern (Length / Jaw Modifications) 100 pieces / reference 10 – 14 working days 25 – 35 working days
New Bespoke ODM Design (New Tooling) 200 pieces / reference 15 – 20 working days 35 – 45 working days

* Lead times are calculated following final sample approval and contract confirmation. Express shipping options available via DHL, FedEx, or air freight.

OEM Inquiries

Frequently Asked Questions

Direct answers regarding contract manufacturing, quality compliance, and international logistics.

Our manufacturing facility in Sialkot operates under an ISO 13485:2016 certified Quality Management System. Reusable surgical instrument product lines are CE marked under EU MDR 2017/745 standards, and our establishment holds active US FDA registration. Technical documentation, declarations of conformity, and heat lot test reports are provided under NDA.

Every steel batch is accompanied by raw material mill test reports verifying chemical composition (AISI 420, 410, 304, 316L) and mechanical properties. All finished instruments undergo ultrasonic cleaning, nitric/citric acid passivation, and rigorous boil/copper-sulfate corrosion testing (ASTM F1089) before release.

Yes. We welcome customer audits at our Defence Road facility in Sialkot by appointment. Furthermore, we routinely facilitate third-party pre-shipment inspections conducted by international agencies such as SGS, Bureau Veritas, or TÜV based on your agreed AQL sampling plan.

Ready to Launch Your Custom Instrument Line?

Connect directly with our senior manufacturing engineers. We provide technical feasibility assessments, sample estimates, and formal quotations within 24 hours.