ISO Certification in UAE
ISO Certification in UAE

ISO 13485 - Quality Management System - Medical Devices

ISO 13485 is an internationally published standard that defines requirements within quality management systems for manufacturers, suppliers, contract service and distributors of medical devices and equipment. The main objective of the standard is to facilitate harmonized quality management system requirements for regulatory purposes within the medical devices sector. ISO 13485 Cerification Standard has been based on the requirements of ISO 9001 standard and has the same structure in terms of clauses. Even some clauses of ISO 13485 have been referred to ISO 9001.

The ISO 13485 standard is for medical devices – quality management systems – requirements for regulatory purposes, is the basis for regulatory compliance in local and most global markets. Exporting medical Devices to various countries is mandatory. ISO 13485 Certification is an objective evidence of compliance of the requirements, regardless of the type or size of the organization.

This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and services

ISO 13485 - Benefits
  • Customer satisfaction
  • Reduced operating costs
  • Improved stakeholder relationships
  • Legal compliance
  • Improved risk management
  • Proven business credentials
  • Ability to win more business

Veritas

ISO Certification in Dubai, UAE.

ISO 9001 Certification

Quality Management System is applicable to virtually any organisation, of any size...

READ MORE

ISO 14001 Certification

Environmental regulations are getting stricter, and so is the law...

READ MORE

OHSAS 18001 Certification

Health and Safety Management Systems. It is essential to...

READ MORE

ISO 45001 Certification

ISO 45001 provides a safe and healthy workplace for your workers and other...

READ MORE

ISO 27001 Certification

Information security systems really helps all enterprises and manufactures to...

READ MORE

ISO 20000 Certification

IT is essential to delivering today's business. However, concerns are...

READ MORE

ISO 22301 Certification

BCMS has been developed to protect companies from the risks ...

READ MORE

View All

ISO Certification
Standards ....

VIEW ALL
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification
iso certification