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Technical file requirement for Class IIb medical device

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class ii medical device, technical files for medical devices
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  Post Number #1  
Old 14th June 2018, 07:16 AM
anpun

 
 
Total Posts: 6
Please Help! Technical file requirement for Class IIb medical device

I have started to create the technical file for Medical device Class IIb product. Could anyone tell me what will be the content of the technical file?? I have confusion whether my technical file will consist of :
1. Does it contain all the procedure of the quality system ISO13485?
2. Does it consist of Product Validation, Process Validation and Software Validation report?
3. If I conduct the product validation then Do I need to do separate software validation process? Cause some of the users needs also consist of the software function.

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  Post Number #2  
Old 14th June 2018, 08:11 AM
BhupinderSinghPawa

 
 
Total Posts: 31
Re: Technical file requirement for Class IIb medical device

Quote:
In Reply to Parent Post by anpun View Post

I have started to create the technical file for Medical device Class IIb product. Could anyone tell me what will be the content of the technical file?? I have confusion whether my technical file will consist of :
1. Does it contain all the procedure of the quality system ISO13485?

>> No

2. Does it consist of Product Validation, Process Validation and Software Validation report?

>> Yes

3. If I conduct the product validation then Do I need to do separate software validation process? Cause some of the users needs also consist of the software function.

>> Software verification in line with IEC 62304 requirements. Software Validation is sum total of software verification and system validation (including the software) to conclude that product / software meets the intended use. Refer FDA guidance on software validation.
The following resources will help you to put together the Technical File.

GHTF STED - Summary of Technical Documentation
http://www.imdrf.org/docs/ghtf/final...ces-080221.pdf

NB MED Technical Documenation
http://www.meddev.info/_documents/R2_5_1-5_rev4.pdf
Thanks to BhupinderSinghPawa for your informative Post and/or Attachment!
  Post Number #3  
Old 14th June 2018, 02:21 PM
anpun

 
 
Total Posts: 6
Re: Technical file requirement for Class IIb medical device

Thanks
Really Appreciated...
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