Purpose of ISO 13485 certification: Medical devices In the medical industry, this ISO 13485 certification is made to be the International Standard under the Quality Management System (QMS). The ISO…
ISO 13485: Medical devices – Quality management systems requirements for regulatory purposes Raw materials Components Subassemblies Medical devices Sterilization services Calibration services Distribution services Maintenance services Hence, the supplier or…
FujiFilms Japan one of the largest conglomerates in Sale, Installation, Service of various types of Medical devices having global presence has signed up with us for the support in ISO…
Difference between management system certification and product certification: ISO 13485 If management conforms that they are meeting all the appropriate and international standards and also provides a proper endorsement that…
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…
