Bilanx Consulting LLC has participated in the development of ISO 14971 medical device risk management standard and can help you develop your own processes and integrate them in your existing quality system as required under ISO 13485:2003. See our article in Biomedical Instrumentation and Technology November-December 2008 on Integrating Risk Management in the CAPA Process at AAMI
IEC 60601-1 the general safety standard for medical devices released December 15, 2005 requires a Risk Management process that complies with ISO 14971. In 2012, IEC 60601-1 3rd Edition and its family of collateral and particular standards will be required for all devices sold in Europe and Canada. See our article in AAMI'sBiomedical Instrumentation and Technology September-October 2006 issue on the use of ISO 14971 with IEC 60601-1.
Bilanx Consulting LLC participated in FDA's Hospital Bed Safety Workgroup anddevelopment 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.
