Samaras’ Blog

Events & Commentary,

Please check out our e-Library                                   as well as references

 to useful materials.

March 2, 2017

Posted portfolio of essays on medical device product development

February 2017

GM Samaras became senior member of National Academy of Forensic Engineers and a Board-certified forensic engineer

September 9, 2016

Commentary: Confronting systemic challenges in interoperable medical device safety, security & usability. Journal of Biomedical

Informatics 63(2016) 226-234.

September 1, 2016

Article published in ASQ Biomedical Division Newsletter BioFeedback Vol 44(2):5-7, 2016:  “What IS my Failure Rate?

April 19-21, 2016

QMED Focus on Fundamentals 3-day Webinar on ”How to Manage Risk Throughout Medical Device Product Development Cycle and

Beyond”.  To access the recorded audio and slide decks, register here.

August 11, 2015

Article published in ASQ Biomedical Division Newsletter BioFeedback Vol 43(2):15-18, 2015:  “Medical Device Life Cycle Risk

Management”

May 20, 2015

Commentary in QMED on risk management: “Premarket vs. Postmarket: Applying Risk Management to Your Device's Entire Lifecycle”

October 31, 2014

Invited Lecture (EA Samaras) at CSU-Fort Collins, “Perspectives on Occupational & Environmental Health Nursing”,  Spectrum of

Professions Protecting and Promoting Worker Health, MOUNTAIN AND PLAINS EDUCATION AND RESEARCH CENTER FOR

OCCUPATIONAL HEALTH AND SAFETY

October 13, 2014

Commentary in QMED on dos and dont’s of medical device design: “Don’t: Use Detectability to Estimate Risk to End-Users

August 13, 2014

Commentary in MD&DI on medical devices and human factors: “The Medical Device Is Safe, But Would I Use It?

February 18, 2014

Commentary in QMED on medical devices and software: “Could-digital-health-make-most-medical-devices-obsolete

September 26, 2013

Commentary on QMED article: “Can Medical Device Engineers and Quality Control Staff Get Along?

July 29, 2013

Article published in MD+DI Online on medical device risk management: Use, Misuse, and Abuse of the Device Failure Modes Effects

Analysis

November 8, 2012

Manuscript on regulated product development and innovation entitled “US Medical Device Innovation: Moving from the Bench to Market” presented at IEEE Healthcare Innovation Conference: Translational Engineering in Health & Medicine, Houston, TX  November 7-9, 2012

August 28, 2012

Tutorial present at IEEE EMBC 2012 (San Diego, CA): “Human Centered Systems Engineering: Human Factors from Lust to Dust”.

August 10, 2012

Article published in MD+DI Online on medical device innovation: Exactly What Medical Device Innovation Are You Talking About?

July 8, 2012

New website launched, replacing 12-year old web pages.

June 18, 2012

Tutorial presented at IEEE PHM 2012 (Denver, CO): “Human-Centered Systems Engineering - Human Factors Engineering and

Reliability”

June 12, 2012

Commentary on medtechinsider article: “Small Companies Suffer Most from US FDA’s 510(k) Process, Survey Says”, originally

published in J. Med. Devices 6, 021015 (2012).

June 2012

Letter to the Editor, June 2012 issue of ASQ Quality Progress regarding risk analysis published: “Risky Tool?

May 23, 2012

Article in Medical Electronics Design published: “Medical Device Mechatronics Maturity”.

April 2012

Medical Device & Diagnostic Industry magazine publishes article: “A Perspective on Invention, Innovation, and Regulation of Medical

Devices”.

March 23, 2012

Online Journal of Nursing Informatics publishes article: “Stakeholder Dissonance as a Critical Determinant of an E-health Initiative: A

Case Study

March 19, 2012

Tutorial presented at IEEE SysCon 2012 (Vancouver, BC): “Human-Centered Systems Engineering: Managing Complex Systems”.

February 12 - 16, 2012

Paper presented at IEA 2012 (Recife, BR): “Recognizing nurse stakeholder dissonance as a critical determinant of patient safety

in new healthcare information technologies”.

Tutorial presented at IEA 2012 (Recife, BR): “Human-Centered Systems Engineering: Human Factors Engineering from Lust to

Dust”.

Paper presented at IEA 2012 (Recife, BR): “Reducing Latent Errors, Drift Errors, and Stakeholder Dissonance: Discriminating

NWDs, Requirements, and Specifications”.

January 2012

Letter to the Editor, January 2012, Communications of the ACM published: “Software Engineering Is Engineering

October 13, 2011

Tutorial presented at IEEE PSES 2011 (San Diego, CA): “Human-Centered Systems Engineering: A Unified Approach to Product

Safety Engineering”.

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