— QUALITY · COMPLIANCE · TRANSPARENCY

Certifications & Regulatory

Quality, compliance and regulatory transparency are fundamental to the way Vision Biotechnology develops, manufactures and supports diagnostic technologies worldwide.

Explore our quality management certificates, regulatory documentation and product compliance resources.

— VERIFIED SYSTEMS

Quality Management Systems

Verified management-system certificates supplied by Vision Biotechnology. Official files remain the controlling records.

ISO 13485:2016 principal document page
ActiveMedical Devices — Quality Management Systems

ISO 13485:2016

Certificate / Reference
QCAS-VBA-24-051581146
Issuing Body
QCAS Certifications Inc.
Scope
Sales of medical diagnostic products, laboratory materials, kits and devices used outside the body.
Issue Date
11 March 2024
Valid Until
10 March 2027
Language
English
ISO 9001:2015 principal document page
ActiveQuality Management System

ISO 9001:2015

Certificate / Reference
QCAS-VBA-24-051581145
Issuing Body
QCAS Certifications Inc.
Scope
Sales of medical diagnostic products, laboratory materials, kits and devices used outside the body.
Issue Date
11 March 2024
Valid Until
10 March 2027
Language
English

— CONFORMITY ASSESSMENT

CE & IVDR

Conformity-assessment status is presented conservatively and only from the supplied confirmation document.

GMED IVDR Confirmation principal document page
In ProgressNotified Body Confirmation Letter · Reference 40531 rev. 0

GMED IVDR Confirmation

Certificate / Reference
Notified Body 0459 · SRN TR-MF-000024208
Issuing Body
GMED SAS
Scope
Confirms receipt of a formal IVDR certification application and execution of a written agreement for device families listed in the supplied letter. This is not an IVDR certificate.
Issue Date
21 May 2026
Language
French / English

— MARKET-SPECIFIC STATUS

Regulatory Registrations

Country registrations are product- and market-specific. No unverified registration count or export-based approval claim is published in this center.

EuropeMiddle EastAfricaAsia-PacificAmericas

— CONTROLLED RECORDS

Declarations & Compliance

Verified management-system certificates supplied by Vision Biotechnology. Official files remain the controlling records.

Vision Biotechnology Trademark principal document page
ActiveTrademark Registration · Nice Classes 01, 03, 05, 10 and 42

Vision Biotechnology Trademark

Certificate / Reference
Registration 2021/15158
Issuing Body
Turkish Patent and Trademark Office
Scope
Registered on 11 September 2022, with protection beginning 29 January 2021.
Issue Date
11 September 2022
Valid Until
29 January 2031
Language
Original document in Turkish · English summary

— CONTROLLED PROCESSES

Manufacturing Quality

Quality is integrated across product development, manufacturing, lot release, traceability and post-market activities. Vision Biotechnology applies controlled processes designed to support product consistency and regulatory compliance across its international operations.

01Incoming Quality Control
02In-Process Control
03Final Product Release
04Lot Traceability
05Stability Monitoring
06Complaint Handling
07Post-Market Surveillance
08CAPA

— VERIFIED FILES

Certificates & Documents

Verified management-system certificates supplied by Vision Biotechnology. Official files remain the controlling records.

Manufacturing Capacity Report principal document page
ActiveIstanbul Chamber of Industry / TOBB

Manufacturing Capacity Report

Certificate / Reference
Capacity Report 2025/283
Issuing Body
Istanbul Chamber of Industry
Scope
Supplied report covering listed PCR and molecular diagnostic manufacturing activities at the Istanbul facility.
Valid Until
14 February 2027
Language
Original document in Turkish · English summary

Historical archive

Manufacturer Certificate
Archived

Manufacturer Certificate

Expired 26 January 2025

Historical English-language document. Archive reference only; it is not current evidence.

View Certificate
Manufacturing Qualification Certificate
Archived

Manufacturing Qualification Certificate

Expired 26 January 2025

Historical document linked to Capacity Report 2023-377. Superseded or renewed documentation is required for current use.

View Certificate

— REGULATORY TRANSPARENCY

Quality You Can Verify.

We believe regulatory transparency should be accessible. Vision Biotechnology provides verified quality and compliance documentation to support customers, distributors and regulatory partners worldwide.

Find Regulatory Information
Need regulatory documentation?

Contact Regulatory Affairs

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