HALO INTERNATIONAL: A Trusted Name in Certified Medical Mobility Solutions
Commitment to Excellence in Medical Certification
At HALO INTERNATIONAL, we take pride in being a globally recognized manufacturer of medical-grade electric wheelchairs backed by the most stringent international certifications. Our CE Mark, ISO 13485 accreditation, and FDA compliance stand as testaments to our unwavering commitment to safety, quality, and innovation in assistive mobility technology.
Why Certifications Matter in Medical Mobility Devices
Medical certifications are not just badges of honor—they represent rigorous validation processes that ensure:
✔ Patient Safety – Every wheelchair meets strict biomedical standards ✔ Clinical Reliability – Consistent performance in healthcare environments ✔ Global Market Access – Compliance with international regulatory frameworks ✔ Quality Assurance – Certified manufacturing processes from design to delivery
Our Certification Milestones
CE Mark Certification (Medical Device Directive 93/42/EEC)
- Awarded for all HALO electric wheelchair models sold in the European Economic Area
- Validates compliance with EU safety, health, and environmental requirements
- Includes Class I medical device classification for mobility aids
ISO 13485:2016 Certification
- Internationally recognized Quality Management System for medical devices
- Covers all aspects of design, production, installation, and servicing
- Annual audits ensure continuous compliance with: ▶ Risk management protocols (ISO 14971) ▶ Biocompatibility standards ▶ Electromagnetic compatibility (EMC) requirements
FDA Registration (US Market)
- Listed with the U.S. Food and Drug Administration as a Class II medical device manufacturer
- Meals 21 CFR 820 Quality System Regulation requirements
- Regular facility inspections by FDA representatives
Beyond Basic Compliance: Our Certification Advantages
While many manufacturers meet minimum requirements, HALO INTERNATIONAL exceeds them through:
Enhanced Testing Protocols
- 200+ hour durability testing beyond standard certification requirements
- Real-world simulation labs replicating hospital corridors, uneven pavements, and incline conditions
Certified Supply Chain
- All components sourced from ISO-certified suppliers
- Traceability systems meeting MDR (EU Medical Device Regulation) requirements
Continuous Certification Development
- Dedicated Regulatory Affairs Team monitoring global standard updates
- Currently pursuing MDSAP (Medical Device Single Audit Program) certification
The HALO Difference: Certified Quality You Can Trust
"Certifications are our foundation, but patient outcomes are our true measure of success," says Dr. Michael Zhang, our Chief Medical Officer. "Last year alone, over 300 healthcare institutions chose HALO wheelchairs specifically because of our certified quality guarantees."
Our certification journey reflects in these measurable outcomes:
- 0 product recalls related to safety issues in the past 5 years
- 40% shorter approval time for hospital procurement processes
- 92% repeat purchase rate from medical facilities
Looking Ahead: The Future of Certified Mobility
As we develop next-generation smart wheelchairs with IoT connectivity and AI navigation, HALO INTERNATIONAL remains committed to:
- Maintaining gold-standard certifications for all new products
- Expanding our MDR compliance for the EU market
- Pioneering new testing methodologies for emerging technologies
For healthcare providers and users seeking fully certified, regulation-compliant mobility solutions, HALO INTERNATIONAL stands ready to deliver.
Contact our certification specialists today to request complete technical documentation for any product line.
