Certifications & Regulatory Compliance

Quality and regulatory compliance are integrated into every stage of our operation — from supplier qualification and incoming material inspection, through design, production, testing, and final shipment — so that every medical rehabilitation device we deliver meets the standards required by your market.

Home/Certifications
ISO 13485
Quality Management
FDA
Market-Specific Regulatory Support
CE / MDR
Product Testing & Inspection
SGS · TÜV
Compliance Documentation Available
OEM / ODM
Regulatory Support
Important: Compliance documentation varies by product and target market. Not every product carries the same certifications — FDA device listing, CE marking, and available test reports differ by SKU and destination. Contact us for product-specific documentation before placing an order.

Certification Summary

Certification Standard Issuing Body Scope Status Action
ISO 13485 EN ISO 13485:2016 TÜV Rheinland LGA Products GmbH Design, Development, Manufacture & Distribution of Rollators, Wheelchairs, Commode Chairs, Bathroom Chairs, Walkers, Crutches & Canes Valid Certified Request Certificate
FDA FDA Establishment Registration US FDA Establishment Registration & Device Listing for rehabilitation devices Registered Request Records
CE / MDR MDR 2017/745 CIBG — Healthcare Inspectorate, Netherlands Rollators, Wheelchairs, Commode Chairs, Walkers, Crutches & Canes MDR Compliant Request Documents

ISO 13485 Quality Management System

DeepTay holds a valid ISO 13485:2016 certificate for its Quality Management System. To prevent unauthorized use or forgery, the full certificate is not published on this website. Official documents are provided to verified business partners — distributors, tender teams, and OEM clients — upon request.

📩 Request ISO 13485 Certificate

FDA Establishment Registration & Device Listing

DeepTay maintains an active FDA Establishment Registration and Device Listing for applicable products. To prevent unauthorized use or forgery, full registration records are not publicly displayed on this website. Official records are provided to verified business partners — distributors, tender teams, and OEM clients — upon request. Contact us to obtain documentation required for your business evaluation, tender, or compliance file.

📩 Request FDA Registration Records
Important Note: FDA establishment registration and device listing do not represent FDA approval, certification, clearance, or endorsement of any product.

CE Marking & EU MDR Compliance

Applicable products meet CE-MDR (EU Regulation 2017/745) requirements. To prevent unauthorized use or forgery, full compliance files are not published on this website. Declarations of Conformity (DoC), UDI documentation, and other compliance files are provided only to verified business partners — distributors, tender teams, and OEM clients — upon request. Contact us to receive the documents required for your market entry, audit, or tender file.

📩 Request CE-MDR Documents

Product Testing & Inspection

Every product family is validated through a comprehensive battery of structural, functional, durability, and packaging tests — both in-house and by internationally accredited third-party laboratories.

Structural Testing

  • Static load testing
  • Dynamic load testing
  • Stability testing
  • Fatigue testing
  • Frame strength testing

Functional Testing

  • Brake performance
  • Wheel and caster function
  • Folding mechanism
  • Locking systems
  • Height adjustment

Durability Testing

  • Repeated operation cycles
  • Component fatigue
  • Surface durability
  • Corrosion resistance

Packaging & Transportation

  • Packaging inspection
  • Drop testing
  • Carton strength
  • Transportation simulation

Third-Party Testing Laboratories

SGS

Third-party validation for material, safety, and performance against EN and IEC standards.

Intertek

International product testing, inspection, and certification services.

TÜV

German-based testing and certification for European market access.

Other Accredited Laboratories

Additional ISO 17025-accredited laboratories as required by specific markets or product categories.

📩 Request Product Test Reports

Compliance Support for OEM & Private Label Projects

When you partner with DeepTay for OEM or private-label manufacturing, we handle the regulatory heavy lifting so your team can focus on branding, distribution, and sales. Our compliance support includes:

  • Assessing target-market regulatory requirements upfront
  • Adapting product designs to meet regional standards (FDA, CE/MDR, etc.)
  • Generating technical files and risk management reports
  • Coordinating third-party testing on behalf of your brand
  • Preparing labeling, IFU, and registration documentation
  • Liaising with Notified Bodies and regulatory authorities when needed

Quality Control Throughout Production

Our multi-stage quality control process ensures every unit meets specifications before it leaves the factory.

1. Incoming Quality Control (IQC)

  • Raw materials and components inspected against specifications
  • Material certificates verified and filed
  • Supplier lot numbers recorded for traceability

2. In-Process Quality Control (IPQC)

  • First-piece inspection at each production stage
  • Critical process parameters monitored in real time
  • Routing inspections between assembly stations

3. Final Quality Control (FQC)

  • 100% functional testing on every finished unit
  • AQL sampling inspection for visual and dimensional checks
  • Packaging and labeling verification

4. Pre-Shipment Inspection

  • Independent QC team performs final audit
  • Container loading verification
  • Random sample pull for full re-test

5. Full Traceability

  • Unique batch ID on every product and carton
  • ERP-linked work orders, operators, and machines
  • Inspection records tied to each finished unit

Documentation Support for Global Buyers

Whether you are a hospital procurement team, a government tender office, a distributor, or an OEM brand owner, we provide the compliance documentation you need to move products through your supply chain and market them with confidence. All documentation is available in English and can be customized to include your company details for private-label projects.

Available Documents

ISO 13485 Certificate

Current ISO 13485:2016 Quality Management System certificate, available upon request.

CE / EU Compliance Documents

Declarations of Conformity, technical files, risk management reports, and Authorized Representative details.

FDA Registration & Listing Information

Establishment registration details, device listing records, and classification information for the US market.

Product Test Reports

Structural, functional, durability, and packaging test reports from SGS, Intertek, TÜV, and other accredited labs.

Technical Datasheets

Detailed product specifications, dimensions, material compositions, and performance parameters for engineering and procurement teams.

Instructions for Use (IFU)

Multi-language user manuals covering assembly, operation, maintenance, cleaning, and safety precautions.

📩 Request Available Documents
Document Notice: All compliance documents displayed on this page represent genuine and valid certifications. For document security and anti-forgery purposes, full certificate files will only be shared with verified business partners after formal request.

Request Compliance Documents

Need ISO 13485 certificate, FDA establishment registration details, CE/MDR Declaration of Conformity, or product test reports for your tender, audit, or compliance file? Request the full compliance documentation pack from our team.

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