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View Full Version : What are the differences between a design dossier and a regular technical file?

J1980b
27th February 2009, 04:26 AM
Hi,

Could anyone tell me what the main differences between just a regular Tecnical file (i.e for a class IIa device) and a Design Dossier (for a class III device)

What extra parts should be included to make up a design dossier?
how should these be documented?

Regards
harry
27th February 2009, 05:24 AM
Scroll down to the 'similar discussion threads' box below and have a look at this thread:Technical File vs. Design Dossier? Class II and Class III Medical Devices (http://elsmar.com/Forums/showthread.php?t=28968)

Your answers are there.