AAMI TIR50: 2014 “Post-market surveillance of use error management” addresses use error detection for medical devices from the clinical, manufacturer, patient, user, and regulatory perspective. The goal is to provide guidance on how these individuals can best collect, assess, and leverage post-market use error data to mitigate product risk, and to improve product safety and...Read More
AAMI has published “AAMI TIR45: 2012 Guidance on the use of AGILE practices in the development of medical device software.” FDA staff was involved in development of this guidance for compliant use of Agile methods. The document can be ordered from AAMI.org.Read More
The pdf at the link provided is a reprint of an article entitled “Risk-Based Validation of Multilingual Medical Devices” co-authored by Alan Kusinitz, Managing Partner of SoftwareCPR, and Kai Simonsen of the Crimson Life Sciences division Transperfect Translations for the AAMI Biomedical Instrumentation and Technology journal and published in the Summer of 2007. Reprinted with...Read More
AAMI Standards Conference Software Session 2005 including 4 FDA presentations The following are all included in the pdf at the following link: AAMI Standards Conference Software Session 2005 Review of Software in Premarket Submissions (new guidance for CDRH and CBER) – David S. Buckles FDA CDRH ODE Cybersecurity for Networked Medical Device Containing (OTS) Off-the-Shelf Software...Read More
This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. At AAMI's International Standards Conference on March 11 2003 FDA's CDRH Software Compliance and Part 11 Representative (John Murray) gave the first presentation on FDA's changes in its approach to Part 11. The slides from this presentation can be...Read More
This content is only available to Premium Level or higher subscribers. See our Subscribe page for information on subscriptions. At AAMI's International Standards Conference on March 11 2003 FDA's CDRH Software Compliance Expert and AAMI Software Committee co-chair (John Murray) gave a presentation on FDA's software message and the role standards can play to benefit industry and...Read More
At a half-day breakout session on the AAMI Medical Device Software Standard, the HIMA Conformance Assessment Tool, UL 1998, the FDA Off-the-shelf software guidance, and other software standards and policy initiatives for the medical device industry was presented as part of the annual AAMI International Standards Conference. FDA and several industry speakers participated. John Murray,...Read More
Updated Risk Management training course now available. Includes:
Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
Why FMEA is incomplete for medical device risk management.