#Iso 13485 2012 pdf iso#
Two new subchapters have been incorporated into the new version of ISO 13485:
#Iso 13485 2012 pdf software#
Here, again, the FDA's influence becomes noticeable.Īccording to chapter 7.3.8, this design transfer would ideally be carried out after verification, but prior to validation, for example to validate products of pilot series.Īlso new is chapter 7.3.10, design and development files, corresponding to the FDA's Design History File.Ĭhapter 7.5.6 on process validation requires more precisely that relevant process' software shall be validated.
New are the demands for documenting " procedures for design and development", including design transfer. Risk management can, but must not be compliant with ISO 14971.Ĭhapter 7.3's structure has been revised in ISO 13485:2016.