Manufacturing

Our Manufacturing Facility & Quality Process

A look at how SUBMED products are made — from facility and process to the quality control steps built into every production run.

SUBMED clean room production floor
Facility Overview

Where SUBMED Products Are Made

SUBMED's manufacturing operations are based in Istanbul, Turkey. Products distributed through SUBMED US (submedus.com) originate from this manufacturing base.

2010
FOUNDED
50+
COUNTRIES SUPPLIED
19
INTERNATIONAL STANDARDS
Manufacturing Process

From Raw Material to Sterile Pack

1

Material Sourcing

Incoming raw materials (nonwoven fabrics, films, components) are sourced and inspected before entering production.

2

Cutting & Assembly

Materials are cut, formed, and assembled into finished drapes, gowns, kits, or pack components.

3

Pack Configuration

For procedure packs and kits, individual components are configured and assembled to the specified pack composition.

4

Sterilization

Sterile products undergo sterilization, such as ethylene oxide (EN ISO 11135), as indicated on individual product pages.

5

QC & Release

Finished goods undergo quality control checks before release for packaging and shipment.

Quality Control

How Quality Is Verified

SUBMED implements quality control measures throughout manufacturing to support compliance with international standards.

STEP 1

Incoming Material Inspection

Raw materials are inspected against specification before entering production.

STEP 2

In-Process Checks

Components are checked at defined points during cutting, forming, and assembly.

STEP 3

Sterilization Validation

Sterile batches are validated against sterilization parameters before release.

STEP 4

Final Release Testing

Finished goods undergo a final inspection before packaging and shipment.

Documentation supporting these quality control steps (e.g., batch records, certificates of analysis) is available to institutional buyers on request.

Compliance

Certifications & Standards

FDA registered
FDA registered
ISO 13485 — Medical Device Quality Management
ISO 13485Medical Device Quality Management
ISO 11135 — Ethylene Oxide Sterilization
ISO 11135Ethylene Oxide Sterilization
ISO 14971 — Risk Management for Medical Devices
ISO 14971Risk Management for Medical Devices
IEC 62366-1 — Usability Engineering
IEC 62366-1Usability Engineering
ISO 9001 — Quality Management
ISO 9001Quality Management

Certification and quality documentation are available for procurement review upon request. See all certifications

For Procurement Teams

Need Manufacturing or Quality Documentation?

Facility audits, quality manuals, certificates of analysis, and sterilization validation records can be requested directly for your procurement review.

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