In order to ensure the proper execution of a QMS under the ISO 13485 certification, the Saudi Food and Drug authority recommends the involvement of all levels of employees in…

We have already discussed about what calibration is according to the ISO 13485 certification and why it is important. In this post we are going to take a look at…

The responsibility of a medical device manufacturer in Saudi Arabia does not end with the release of the device. According to the ISO 13485 certification required by the Saudi Food…

Calibration being one of the significant requirements for ISO 13485 according to the Saudi Food and Drug Authority, consultants stress on the importance of this process for obtaining the certification.…

One of the significant requirements in the ISO 13485 certification standard is the need for proper calibration of all medical devices. Consultants are of the view that accuracy and precision…

For medical device manufacturers in Saudi Arabia, the ISO 13485 certification is one of the required Quality Management System (QMS) standards. The following are some of the general QMS requirements…

As per the requirements of the ISO 13485 certification, all involved personnel must have the requisite training, skills and competency required to perform their duties. For achieving the certification as…

One of the essential requirements for any company in Saudi Arabia to achieve the ISO 13485 certification is to choose the right consultants for the job. Here are some tips…

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…

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…