Five members attended the meeting on Nov 6, 2014 at The Royal Cantonese in Vernon Hills: Patricia Spillar, Robert Gould, Kelly Rodkey, Regina Fullen, and Dave Taylor.
We continued our study of ISO 14971 Medical devices, Application of Risk Management to Medical Devices. We started reading and discussing From Annex G Information on Risk Management Techniques, and got to Annex section H1 Guidance for Risk Management Techniques In-Vitro Diagnostic Devices.
Patricia Spillar pointed out some on-line training materials from the FDA. After some Discussion we decided to do the training after completion Annexes H, I and J. Probably this will be done in in February or March 2015.
The next meeting will be will be held on December 4 at the Royal Cantonese in Vernon Hills. Across the street from Dover Straits. The scheduling of the January meeting will be discusses in December as the first Thursday will be on New Years Day.
As always, a very delicious meal will be served for $5.00 (free for members searching for a position), the balance being funded by ASQ section 1212 Northeast Illinois. The public is always invited and we welcome your questions about ISO or other standards. Let me know if you have particular subjects to discuss.
Contact Dave Taylor at <firstname.lastname@example.org> if you have any questions or need directions or copies of standards