Technical file requirement for Class IIb medical device

anpun

Registered
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.
 
B

BhupinderSinghPawa

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/fina...safety-performance-medical-devices-080221.pdf

NB MED Technical Documenation
http://www.meddev.info/_documents/R2_5_1-5_rev4.pdf
 
J

Jnks_Meddev

Attachments

  • ghtf-sg1-n063-2011-summary-technical-documentation-ivd-safety-conformity-110317.pdf
    161.9 KB · Views: 359
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