Help for implementing ISO 13485 (provision of software to Hospitals)

R

raghav_gh

#1
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 :confused:). Looking forward for your help..
 
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K

KN Quality

#3
Re: Help for implementing ISO 13485

The first step to implementation is the writing and documenting of your processes in the form of a quality and procedures manual. Have you already completed this?
 

harry

Super Moderator
#4
You may want to start off by comparing the requirements of the standard (need a copy of the standard) versus what you have or are currently practicing - also known as gap analysis. Next you may want to come out with a flow chart to identify the processes and their interactions before starting with the documentation.

There are previous discussions here, here and here.
 
R

raghav_gh

#5

@ KN Quality

I have not started documenting as of now. Right now i have only FDA documents. May be i can map some of the FDA documents to ISO 13485.

@ Harry
(need a copy of the standard) you want to say ISO standards? For CE we have classified the device as Class II A & also I have come up with list of applicable hormonized standards.
 
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