/docs/FDAinfusionpumplifecycleguidance-ucm209337.pdfRead More

http://tinyurl.com/lqw6oyuRead More

A January 2014 ACM Journal has an interesting article on software verification at NASA JPL for the Mars Curiosity Rover at the link provided. A few things that I found interesting: Their standard for flight software is ISO-C99. The coding standard at JPL (http://lars-lab.jpl.nasa.gov/JPL_Coding_Standard_C.pdf) is risk-based and has 6 “levels of compliance”. LOC-5 and LOC-6...Read More

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/ucm202511.htmRead More

The pdf at the link provided is a list of detectable flaws which a manufacturer could be expected to identify and remove. This was provided to the 62304 working group by the FDA for consideration during the work on the second edition of 62304.Read More

/docs/FDAInfusionPumpLetter042310.pdfRead More

Brian Fitzgerald Deputy Division Director, Division of Electrical and Software Engineering, FDA CDRH, Office of Science & Engineering Laboratories, provided a list of software analysis tools FDA’s laboratory uses in evaluating medical device code. This was in response to a question posed at a recent AAMI Webinar that John Murray of FDA and Alan Kusinitz...Read More

Company: MedRx Inc.Product: “Otowizard” and “Vet Digitizer” Date: 3/1/04 Your firm failed to establish and maintain procedures to adequately control environmental conditions that could reasonably be expected to have an adverse effect on product quality as required by 21 CFR 820.70(c). There was no electro-static discharge (ESD) procedures or other precautions in effect when electronic...Read More