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Hi,
This is my first thread, We are small company providing software to Hospitals which helps them in fetching the Dicom’s images from modality and stored on our servers. From where the radiologist can view the images & report for the same. Now the question is we don’t have any QMS implemented & we are planning to get ISO13485 & CE marking to enter in the European market. Can some one help me on how to start up the QMS implementation? And also I want to know what would be the estimated time required to ISO13485. We have limited resources (Actually its only me
). Looking forward for your help..
This is my first thread, We are small company providing software to Hospitals which helps them in fetching the Dicom’s images from modality and stored on our servers. From where the radiologist can view the images & report for the same. Now the question is we don’t have any QMS implemented & we are planning to get ISO13485 & CE marking to enter in the European market. Can some one help me on how to start up the QMS implementation? And also I want to know what would be the estimated time required to ISO13485. We have limited resources (Actually its only me