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ISO 13485:2003 Certification


ISO 13485:2003 Certification


We offer effective ISO 13485:2003 Certification services to organizations of all scale- small and large. The ISO 13485:2003 Certification that we offer is designed to include the latest trends and developments so that we can offer the clients with the best possible services. We ensure that the clients feel confident by assisting them through every stage of the ISO 13485:2003 Certification process. Our ISO 13485:2003 Certification services are reputed for their excellent value for money.

This is an industry specific management standard specially developed for medial devices manufacturing industry. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.

Systemic Requirements
  • Establish a quality system for medical devices
  • Document your medical device quality system

Management Requirements
  • Support quality
  • Focus on customers
  • Establish a quality policy
  • Perform quality planning
  • Control your quality management system
  • Carry out management reviews

Resource Requirements
  • Provide quality resources
  • Provide quality personnel
  • Provide quality infrastructure
  • Provide quality environment

Application
All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.


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