ISO 13485 Quality management for medical devices

ISO 13485 Quality management for medical devices

ISO 13485:2016 Certification

ISO 13485 Certification | Medical devices - Quality management
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

It is the "de facto" standard for global medical device QMS compliance for medical devices, and is a prerequisite for access to most major markets worldwide.

ISO 13485 Certification - Benefits
 Meet Regulatory Requirements
 Demonstrate that medical devices are produced safely & Communicate your high standards of quality
 Gain a competitive edge
 Reducing operating costs
 Establishing business credentials
 Improved stakeholder relationships
 Ensuring Legal compliance
Ensuring Customer satisfaction
Improving risk management


ISO 13485 – Medical Devices Certification
Home ISO 13485 – Medical Devices Certification
IS0 13485 Certification And Consultation Training in UAE, Dubai, Riyadh, Muscat
A Must Consulting For Any Medical Company:

ISO 13485 Consultancy certification has been launched in UAE, Saudi Arabia, Oman..Should you require assistance in ISO 13485 Certification, ISO 13485 Consultancy and located in Shrajah, Abu Dhabi, Singapore, Kuwait, Dammam Saudi Arabia, Indonesia, Maldives, Estonia, Tunisia, Oman, Muscat, Albania, Mongolia, Sri Lanka, Egypt, Turkey, Mauritius, Seychelles,Russia, Romania, Fiji Islands, South Africa, Israel, Tripoli – Libya, Iran, Jordan,Algeria, Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Rep., Chad, Congo, Congo, Dem. Rep., Cote d`Ivoire, Djibouti, Egypt, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Libya, Madagascar, Malawi, Mali, Mauritania, Mauritius, Morocco, Mozambique, Namibia, Niger, Nairobi, Nigeria, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, Sudan, Swaziland, Tanzania, Togo, Tunisia, Uganda, Zambia, Zimbabwe, Dubai, Abudhabi, Sharjah, Ras-al-khaimah, Fujairah, Um Al Quwain ,Abha, Al-hasa, Al-Khobar, Baha, Dammam, Dhahran, Hail, Jeddah, Jizan, Jouf, Jubail, Najran, Qassem, Qatif, Riyadh, Tabouk, Taif, Yanbu, Kurdistan call us on +971 50 4773274.

The program for ISO 13485 includes

1. Writing ISO 13485 Manual, Medical Device File for your organization

2. Writing procedures as per the ISO 13485 standard

3. Designing forms for implementing Quality for your medical system

4. Audit based on the ISO 13485 standard

5. Review resources and process improvements and validation

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ISO 13485 Certification : Medical Device Quality Management System What is the purpose of ISO 13485 Certification? ISO 13485 Certification is the medical device industry’s
Basics ISO 13485 Certification  is an international standard that defines the requirements for the Quality Management system for the manufacturers, contract services, suppliers, distributors of