ISO 13485 being one of the most important certifications for medical device manufacturers, most businesses look towards expert consultants in order to make the certification process smooth. Here are some top tips for getting the certificate.

• Be sure to prepare your Medical Device File (MDF) well in advance before the audit.
• Create an internal audit plan in order to assess your current quality management system.
• Engage all stakeholders involved in the process for maximum efficiency.
• Abide by the Saudi Food and Drug Authority guidelines.
• Be sure to perform quarterly management reviews.
• Ensure the proper validation of all electronic quality systems and associated software.

For ISO 13485 Certification, ISO 13485 Consultancy , ISO 13485 Consultants, ISO 13485 SFDA requirements in Riyadh, Jeddah, Dammam, Jubail, Yanbu, Hofuf  drop an email to [email protected].