Proper documentation is one of the essential prerequisites for ISO 13485 certification. Yet, according to most consultants this is where medical device manufacturers tend to trip up. Here are the top mistakes that you should avoid during ISO 13485 documentation control.

  • Use of documents without appropriate approval or review.
  • Unintended use of documents that are out-of-date or no longer relevant.
  • Improper revision tracking and change management.

These are only some of the pitfalls to guard against during documentation. It is advisable to take the help of top ISO 13485 consultants in Saudi Arabia to help your business make the cut for the certificate.

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].

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