The paper at the link provided was written by Mark Paulk of the SEI. It compares ISO 9001 and the Capability Maturity Model (CMM). Although there are some differences between ISO 9001 and the FDA Quality System Regulation, both in content and enforcement, this paper may be helpful for medical device software developers involved in...Read More

/docs/CBER-BECS510kLetter1994.pdfRead More

http://www.fda.gov/cdrh/ode/784.htmlRead More

http://www.fda.gov/cber/gdlns/bldestcomp.htmRead More

/docs/PACSguidance.pdfRead More

http://www.fda.gov/cdrh/ode/odegr823.htmlRead More

/docs/fdagmpcomputerinspectionguide1992.pdfRead More

/Docs/7132a-425-400.PDFRead More

/Docs/7132a-425-100.pdfRead More

/Docs/7132a-425-200.PDFRead More

/docs/fdaswtechnicalreference1987.pdfRead More

/Docs/7132a-425-500.PDFRead More

/Docs/7132a-425-300.PDFRead More

/docs/militarystandard-safety.PDFRead More

/Docs/FDAdrugswguidanceFeb1983.pdfRead More

Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report:3/26/2014 Class lI: PRODUCT syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673 Recall Number Z-1216-2014 REASON Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one...Read More