Surgivalley Surgivalley
Get Quote
ISO 13485 Certified
German Stainless Steel
15,000+ Products
Serving 60+ Countries
CE Marked Instruments

QUALITY ASSURANCE

Uncompromising Quality Standards

Every instrument tested, inspected, and certified before it leaves our facility

Our Certifications

ISO 13485:2016
Medical Device Quality Management System

International standard ensuring consistent design, development, production, and delivery of medical devices.

CE Marking
European Conformity

Products meet EU health, safety, and environmental protection standards for medical devices.

ISO 9001:2015
Quality Management System

Organization-wide quality management ensuring customer satisfaction and continuous improvement.

FDA Registered
US FDA Establishment Registration

Facility registered with the US Food and Drug Administration for medical device manufacturing.

Our Quality Control Process

1

Raw Material Inspection

Incoming German stainless steel verified for chemical composition, hardness (HRC), and surface quality.

2

In-Process Checks

Dimensional accuracy, alignment, and surface finish verified at every manufacturing stage.

3

Heat Treatment QC

Hardness testing (Rockwell HRC 40-50) after heat treatment ensures optimal cutting performance.

4

Functional Testing

Each instrument tested for jaw alignment, cutting ability, locking mechanism, and ergonomic function.

5

Surface Inspection

Visual and magnified inspection for surface defects, polish quality, and engraving accuracy.

6

Final Audit & Packaging

100% inspection before sterile packaging. Lot traceability maintained for every batch.

Materials & Specifications

Standard Instruments

Material
AISI 420 German Stainless Steel
Hardness
HRC 40-44 (Handles) / HRC 48-50 (Cutting edges)
Finish
Satin / Mirror / Sand blast
Sterilization
Autoclave compatible (134°C)

Tungsten Carbide (TC)

Insert Material
Tungsten Carbide (TC) jaw inserts
Advantage
5x longer grip life than standard
Identification
Gold-colored handles
Applications
Needle holders, forceps, scissors