Consultants advice medical device manufacturers in Saudi Arabia to prepare for ISO 13485 certification by creating a medical device file (MDF). It is imperative to create a MDF for smooth certification.

In order to create the MDF, one must adhere to the rules and regulations laid down in the 13485 practical guidebook. The MDF must include necessary documents for the purpose of demonstrating conformity. This can be done by creating a cross-reference list tabulating the requirements.

For best results it is recommended to take the help of professional consultants in preparing the MDF; this helps to guarantee conformity.

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].