ISO 13485 SFDA Requirements Certification in Riyadh, Jeddah

Few of the key features and requirements of the SFDA Saudi Food and Drug administration Riyadh and Jeddah for Medical device manufacturers, medical device distributors and medical device service providers

• Verify MDR procedures comply with regulatory requirements
• verify medical device company maintains MDR event files that comply with regulatory requirements
• confirm medical device company appropriate MDR information is identified, reviewed, reported, documented, and filed
• ensure medical device company is effective in identifying MDR reportable events
• ensure medical device company has established procedures for receiving, reviewing, and evaluating complaints
• verify medical device company maintains complaint files and that they are reasonably accessible
• confirm medical device company that complaints are evaluated to determine if an event should be a MDR
• ensure complaint investigations include the device name, date of complaint, device identification number, contact information of complainant, details of complaint, date and results of investigation

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