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.

Medical device links

FuturePundit is one of my other favorite blogs, check out this post on Resveratrol and this one on an implanted device that tells you when you're full.

FDA CDRH may tell you about your 510(k) and PMA submission problems as they find them.

Stent startups are still popular among VCs. Why stents? There are a million stent companies out there.

Medical device industry, all boom, no bust.

University of Minnesota opens a medical device center, trying to keep Minneapolis/St. Paul as the place to be for cardiology devices.