Our partner Windi Hary and I annotated a recent FDA Warning Letter.  There is much one can learn from Warning Letters and we highly encourage our clients to make review and analysis of warning letters a regular part of your quality program. Click here to download this teaching aid:  Warning Letter – iRhythm Technologies, Inc...Read More

When considering software process and software validation requirements for “product software” versus “tool software,” it can be very confusing and challenging.  We have created a job aid that can help facilitate the discussion of the differences between the two.  Product software runs as part of the product, whereas tool software is software running a tool...Read More