Bilanx Consulting LLC

Product Risk Management

ISO 14971 the Medical Device Risk Management standard has been Recognized by the US FDA, as well as other countries' medical device requirements. Bilanx Consulting LLC has participated in the development of this widely accepted standard, can help you develop your own processes and integrate them in your existing quality system as required under ISO 13485:2003. IEC 60601-1 the general safety standard for medical devices released December 15, 2005 requires a Risk Management process that complies with ISO 14971. See our article in AAMI's Biomedical Instrumentation and Technology September-October 2006 issue on the use of ISO 14971 with IEC 60601-1 at AAMI

Bilanx Consulting LLC participated in FDA's Hospital Bed Safety Workgroup and development of FDA's Hospital Bed Siderail Guidance. All bed manufacturers and medical facilitites should review this document. See http://www.fda.gov/cdrh/beds/ for more information. See our article in AAMIs' Biomedical Instrumentation and Technology May-June 2007 issue on the work of HBSW at AAMI.

See our article on Postdevelopment Risk Management at
http://www.devicelink.com/mddi/archive/04/05/025.html.