Medical First Article - Can it be a Delta?

AGillespie

Registered
I recently transferred from aerospace to medical.

In aero I could do a partial delta FAI to document a change to a part. An example would be a customer drawing revision where 1 dimension out of 100 changed. We could do a delta FAI citing the previous document revision, what the change was and then the dimensional measurement.

Are delta FAI's allowed in medical? Has anyone tried to use a delta in medical?
 

Tidge

Trusted Information Resource
In medical device design, it is typical that design outputs go through a dedicated release in order to obviously satisfy the requirements of 13485 (such as 7.3.9 and 4.2.4) and in the USA 21 CFR 820.30 (multiple, including (i) and (j)).

There may be some more flexibility with respect to particular records (e.g. records of part inspection per 820.80 in the USA) but I think this would be recognized as a very slippery slope.
 
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