Penelope Trunk has an interesting post on Jake Breeden's  Tipping Sacred Cows  which  lists sacred cows in corporate life that we shou...

Note: This is the final part of the medical devices particle testing tech talk, see part 1 and part 2 . Once the particulate test metho...

I previously discussed testing medical devices in blood here (in 2007!), but I think I did a poor job of it and I’d like to revisit it. ...

One important consideration to take into account while designing and testing medical devices is how they’re going to be used. In the case of...

I sometimes enjoy The Oil Drum’s tech talks , so I thought I’d give one a try. Guide wires, or guidewires, are used in the vasculature to a...

There is not that much information about the attribute gage (gauge) R&R readily available online (that I was able to find), so I thought...

I'm searching for a reason and here is the one I came up with: The world expert resides in the US and you really need her on your team ...

Law Firm IT has an interesting post on installing the latest Windows patches on medical devices, including this: "...because the machi...

Patrick in the comments asked a while ago: We have a radioactive device, and the act of charging with radiation has an impact on the surface...

We moved our happy medical device company down the road and I've been spending my time working on projects related to moving. Thrilling...

Medical device blogger addresses technical questions The picture looked less geeky when I picked it out. Our packaging design went fairly sm...

I know how Creo Quality (sorry to post off of Creo so much, but I can't find many other device blogs) feels, the closer you get to your...

I've spent the last few weeks dealing with bench tests as we wait for other results to come in. Bench testing or performance testing ge...

I posted previously on failing a natural product sterility (NPS) test in a lot release using ethylene oxide (ETO) sterilization, and we fin...

As part of our company growing up, and failing a sterility test , we've put the quality department in charge of samples instead of manuf...

One part of the ETO sterilization validation we're performing involves testing the natural product sterility (NPS). This entails steri...

I thought I'd answer some questions that people have attempted to find answers for on this blog, keep in mind that I'm no expert- an...

The powers that be have recently started discussing moving the company down the street to a slightly bigger, nicer, cheaper place. If this ...

Medical Device Technology has put " How to Validate a Packaging Process " online which contains pretty thorough information. I...

I spent today writing the biocompatibility testing protocol which is required for product validation, engineers writing testing protocols is...