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- How can ISO 13485 certification in South Africa help with MDR compliance?As a medical device manufacturer, if you are implementing an ISO 13485:2016 certification in South Africa Quality Management System (QMS), you may wonder how the new European Union Medical Device Regulations (EU MDR) affect you, and how your Quality Management System can help with meeting these new requirements. This article will assist to give an explanation for the relationship between these...0 Comentários 0 Compartilhamentos 800 Visualizações 0 Anterior
- How to comply with the MDR requirements for medical device labelsAccording to the definitions in the European Union’s Medical Device Regulation (MDR) “label” ability any written, printed, or image statistics acting both on the system itself, or on the packaging of every unit or on the packaging of a couple of devices. The cause of the labeling manner is to pick out a Medical machine and its manufacturer, and to speak necessary data on...0 Comentários 0 Compartilhamentos 735 Visualizações 0 Anterior
- How to perform ISO 13485 training in Qatar?Implementing a Quality Management System (QMS) for your medical system manufacturing organization the usage of the necessities of the ISO 13485:2016 certification in Qatar is standard can be difficult. Along with figuring out what wants to be finished inside your employer to meet the necessities of the standard, and imposing these processes, you will additionally want to make sure that you have...
- How to write a good ISO 13485 Quality Policy?When enforcing a Quality Management System (QMS) for your medical device manufacturing organization, you will discover that one of the first matters you want to write in accordance with ISO 13485:2016 certification in Qatar is your Quality Policy. So, you may also marvel at what this Quality Policy is and why it is indispensable for the QMS. In this article, we will observe this vital...
- Production and service provision process in ISO 13485 certification in Qatar?Clause 7.5 of ISO 13485 certification in Qatar, which offers requirements for manufacturing and provider provision, motives a lot of confusion. The predominant cause for this is the truth that the preferred targets to outline necessities relevant to a extensive range of manufacturing and carrier provision strategies in the clinical gadget industry. The necessities had to be regular, adequate to...
- Production and service provision process in ISO 13485 certification in South AfricaISO 13485 certification in South Africa, which offers necessities for manufacturing and provider provision, causes a lot of confusion. The major cause for this is the truth that the preferred pursuits to outline necessities relevant to a vast range of manufacturing and provider provision techniques in the clinical gadget industry. The necessities had to be standard sufficient to observe...0 Comentários 0 Compartilhamentos 731 Visualizações 0 Anterior