Jul 12, 2008

File work

I've been working on a ton of paperwork the last couple weeks, getting our ISO 13485 technical file, design history file (DHF), and device master records (DMR) in order. Putting these three in order doesn't require any actual "work" it is just referencing things that have already been done. For example, all three require product specifications.

We release our important protocols and reports as controlled documents so I generally just write a page referencing whatever needs to be referenced and if someone wants to, they can dig through the master file. They will curse me for not making copies and putting them in the tech file, DHF or DMR, but it is not a requirement to make it easy for anyone and in general we don't work from these files, but from the working copies of drawings/reports/whatever on the server. Thirty years from now maybe regulators will get together and combine the file requirements into one, although that would take away some of the fun.

3 comments:

Bob Walton said...

A tedious process indeed, but if it wasn't done for the CDRH/FDA, think of how much longer the PMA process would take?

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justin said...

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