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ISO 13485 Communications Best Practices

Consultants over the world agree on the fact that proper communication is one of the key requirements of the ISO 13485 certification. Poor communication practices such as reliance on verbal...

Top Advantages Of ISO 13485 Based QMS

It may often become difficult for consultants to explain the benefits of the ISO 13485 certification to company executives. In light of this difficulty, here are the top few advantages...

ISO 13485 Product Design Issues

Among the many requirements of the ISO 13485 certification as required by the Saudi Food and Drug Authority, product design is one of the important ones. As per the ISO...

Why Spreading Awareness For ISO 13485 Is Important

The Saudi Food and Drug Association (SFDA) urges all medical device manufacturers to get the ISO 13485 certification. ISO 13485 consultants all over the world, including in Saudi Arabia, are...

Factors Which Determine ISO 13485 Calibration Frequency

Calibration of medical devices is an issue given prime importance in the ISO 13485 certification standard. The SFDA, along with top consultants in Saudi Arabia agree on the fact that...

Four Reasons Product Owners Should Get ISO 13485 Certification

Despite repeated insistence from the Saudi Food and Drug authority for getting the ISO 13485 Certification, medical product manufacturers may feel reluctant to get the certificate. This is because the...

How To Engage Top Management In ISO 13485 QMS

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...

Advantages Of ISO 13485 Calibrations

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...

Top ISO 13485 Tips For Measuring Product Performance

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...

Top Tips For ISO 13485 Calibration

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....