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ISO 13485 Certification

Saudi ISO 13485 Consultancy, ISO 13485 Certificate, ISO 13485 certification, ISO 13485 Certification Jubail, ISO 13485 Certification Yanbu, ISO 13485 Certification Riyadh

Medical devices manufactured and serviced in Saudi Arabia have to comply to the requirements of Saudi Food and Drug administration SFDA. Medical devices QMS is called as ISO 13485 and it is important to identify the risk levels associated in manufacturing the medical equipments. Be it implants or devices which are used for external scanning, all organizations manufacturing and servicing medical devices have to be certified to ISO 13485:2016 version.

Ten (10) Steps for ISO 13485 Certification in Saudi Arabia


  1. Identify a Saudi company which provides ISO 13485 consultancy and certification support
  2. Check if the consultant is an approved ISO 13485 auditor
  3. Ensure if consultants is aware about conducting Risk assessment based on ISO 14971
  4. Check if the consultant provides all ISO 13485 documentation support
  5. Check if the consultant provides turnkey solution for ISO 13485 Medical device Management
  6. System Certification.
  7. Conduct ISO 13485 Gap analysis
  8. Conduct ISO 13485 Training
  9. Plan and conduct ISO 13485 Internal audit, review meeting
  10. Invite third party assessment body to review and audit your ISO 13485.

Why is ISO 13485 Certification important ?


Medical equipments which are certified and produced or serviced in ISO 13485 Certified companies confides in customers be it in hospitals, medical centers, polyclinics in Saudi Arabia.


Finally, the patients who are subjected to tests using these equipments have to feel satisfied with respect to the reports generated.


Implants which are embedded in patients have to be comply to Saudi Food and Drug administration SFDA requirements and have to follow stringent quality control processes in their factories. Service organizations which have the service capability to repair and service medical equipments have to prove that their systems are complying and capable to meet service design requirements.


What are the eleven (11) important documents required in ISO 13485 certification?


  1. Context of the organization
  2. Risk assessment based on ISO 14971
  3. Application of all the ISO 13485 Clauses and maintaining related ISO 13485 Documents.
  4. Design Failure mode effect analysis.
  5. Procedure for Special process validation
  6. Compliance to ISO 13485 legal requirements
  7. ISO 13485 Manuals and procedures.
  8. Software validation
  9. Notifications with respect to Advisory services
  10. Clean room validation
  11. Design and development Verification, Validation

contact for ISO 13485 Certification Jubail, ISO 13485 Certification Yanbu, ISO 13485 Certification Riyadh

Mobile :- Mr. OMER 053 322 4838
KINGDOM OF SAUDI ARABIA
E-mail :- info@iso-saudi.net
Web :- http://www.iso-saudi.net

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