QUALITY & COMPLIANCE
Distributor Quality System
Ventiqua maintains a quality management system aligned with applicable requirements for medical device distributors, including supplier control, traceability, and post-market surveillance.
Regulatory Compliance
Ventiqua operates in accordance with the South African Health Products Regulatory Authority (SAHPRA) medical device regulatory framework.
Device registration and licensing processes are managed in alignment with regulatory requirements
Manufacturer Oversight
The Selethru PTCA Balloon Catheter is manufactured by Kossel under an ISO 13485- certified quality management system.
Post-Market Surveillance
Ventiqua maintains procedures for:
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Complaint handling
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Vigilance reporting
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Field safety corrective actions
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Traceability and recall support
Compliance Statement
Information on this website is provided for professional reference only and does not replace the manufacturer’s Instructions for Use.