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Medical devices, VMP and product Validation

M

MIREGMGR

#11
#11
You may wish to note that this FDA document is issued only by CDER, CBER, CVM and ORA. If your concern is medical devices i.e. CDRH, the applicable guidance is in fact the above-referenced GHTF document, in the creation of which CDRH played a key role. Tim Ulatowski, the CDRH Director of Enforcement, is a major proponent of GHTF efforts.
 
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J

Juan Dude

#12
#12
alex.Kennedy said:
I would be very reluctant to use the above referenced document (Juan's document) . It would appear to be written in isolation with no regard to some of the fundamental issues that the regulations spell out.
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The FDA's Center for Devices and Radiological Health (CDRH) has full involvement on the publication of the GHTF Process Validation Guidance, therefore it's in compliance of FDA regulations, read this: http://elsmar.com/Forums/showpost.php?p=299455&postcount=9

alex.Kennedy said:
Then again there is no reference to executing a Design Qualification. So you are not qualifying your design before construction.

The Design Qualification (DS) is executed as the final verification that the Design Specification (DS) will deliver the requirements that the end user has detailed in the User Requirement Specifications (URS), and that the design is compliant with all applicable regulatory, company, health and safety requirements.
Click to expand...
The link I referenced to is for the GHTF Process Validation Guidance, NOT design validation, this is pretty clear if you read the document's "scope" section.
 
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