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Quality Certifications

Our commitment to excellence is backed by international quality standards and certifications for serving healthcare facilities across India

CE

CE Certified

European Conformity certification ensuring our products meet EU health, safety, and environmental protection standards.

  • Compliance with EU directives
  • Rigorous safety standards
  • International recognition
ISO

ISO 13485 Certified

International Organization for Standardization certification for medical device quality management systems.

  • Quality management system
  • Regulatory requirements
  • Continuous improvement
FDA

FDA Approved

U.S. Food and Drug Administration approval ensuring our products meet American safety and efficacy standards.

  • US regulatory compliance
  • Safety and effectiveness
  • Quality assurance
CDSCO

CDSCO Approved

Central Drugs Standard Control Organization approval for medical devices in India ensuring compliance with national regulations.

  • Indian regulatory compliance
  • Safety and efficacy standards
  • Market authorization
BIS

BIS Certified

Bureau of Indian Standards certification ensuring our products meet Indian quality and safety standards.

  • Indian quality standards
  • Product safety compliance
  • Consumer protection

Why Certifications Matter

Our certifications demonstrate our unwavering commitment to quality, safety, and regulatory compliance across India's healthcare sector.

Quality Assurance

Our certifications guarantee that every product meets the highest international and Indian quality standards.

Safety Standards

Rigorous testing and compliance ensure patient safety and protection in medical equipment usage.

Regulatory Compliance

Full compliance with Indian and international healthcare regulations for seamless operations.

Customer Trust

Our certifications build confidence among healthcare providers across India in our products and services.

Trust Certified Excellence

Partner with Medspy for quality-assured medical equipment backed by international certifications

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