ISO Saudi has recently signed a contract with ‘Leader Healthcare Group’ for the implementation of the ISO 13485:2016 standards for their company based in Jeddah. Leader Healthcare is a super…
Leader Group kick starts ISO 13485 Certification Seven Steps for ISO 13485 Certification in Jeddah at LEADER HEALTHCARE Conducting Risk assessment based on the ISO Standards Preparation of Design control…
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…
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…
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…
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…
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…
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…
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…
