Quality + Compliance +
Global Trust & Standards
AI Dispo operates under uncompromising international quality management systems. Every product batch is accompanied by comprehensive Certificate of Analysis (CoA) and complete batch traceability.
ISO 13485:2016
Medical Devices Quality Management System
Design, automated injection molding, assembly, ETO sterilization and distribution of sterile hypodermic syringes, IV cannulas & infusion sets.
CE Mark MDR (EU 2017/745)
European Medical Device Regulation Class IIa / IIb
Sterile single-use medical devices conformity assessment for 27 European Union member states and EEA territories.
WHO-GMP Certificate
World Health Organization Good Manufacturing Practices
Validated Class 100,000 cleanroom manufacturing, HVAC laminar air flow monitoring, pyrogen control, and sterility validation.
US FDA 510(k) Master File
FDA Device Master File (DMF) & Facility Registration
Polypropylene raw material biocompatibility (ISO 10993 cytotoxicity, hemolysis, systemic toxicity) and device master files.
ISO 9001:2015
International Quality Standard
Enterprise supply chain integrity, automated trace & track, customer satisfaction index, and continuous zero-defect improvement.
Free Sale Certificate (FSC)
Global Export Authorization
Unrestricted export approval for 80+ international sovereign health ministries across Middle East, Africa, LatAm, and Asia.
ISO 13485:2016
Medical Devices Quality Management System
Design, automated injection molding, assembly, ETO sterilization and distribution of sterile hypodermic syringes, IV cannulas & infusion sets.
CE Mark MDR (EU 2017/745)
European Medical Device Regulation Class IIa / IIb
Sterile single-use medical devices conformity assessment for 27 European Union member states and EEA territories.
WHO-GMP Certificate
World Health Organization Good Manufacturing Practices
Validated Class 100,000 cleanroom manufacturing, HVAC laminar air flow monitoring, pyrogen control, and sterility validation.
US FDA 510(k) Master File
FDA Device Master File (DMF) & Facility Registration
Polypropylene raw material biocompatibility (ISO 10993 cytotoxicity, hemolysis, systemic toxicity) and device master files.
ISO 9001:2015
International Quality Standard
Enterprise supply chain integrity, automated trace & track, customer satisfaction index, and continuous zero-defect improvement.
Free Sale Certificate (FSC)
Global Export Authorization
Unrestricted export approval for 80+ international sovereign health ministries across Middle East, Africa, LatAm, and Asia.
Accreditation Details & Standards Scope
ISO 13485:2016
Medical Devices Quality Management System
Full manufacturing lifecycle of sterile hypodermic single-use syringes, peripheral IV cannulas, IV infusion sets, and hypodermic needles.
CE Mark MDR (EU 2017/745)
European Union Medical Device Regulation Conformity
Free commercial placement throughout all 27 EU member states, EEA, and international nations harmonized with European MDR.
WHO-GMP Certificate
Good Manufacturing Practices for Medical Consumables
Class 100,000 cleanroom HVAC positive pressure validation, endotoxin bacterial testing (LAL), sterility assurance validation.
US FDA 510(k) Device Master File
FDA Facility Registration & Biocompatibility Dossier
Device master files (DMF) for polypropylene resin formulations, cytotoxicity, systemic toxicity, and hemocompatibility.
ISO 9001:2015
International Quality Management Standard
Corporate governance, international logistics integrity, supply chain traceability, and continuous customer satisfaction indexing.
Free Sale Certificate (FSC)
Global Export Authorization & Health Attestation
Legal export permit validating that all products sold domestically in India meet identical statutory quality standards as exported batches.