22.10.2018

Ansi/aami He75 2009 Edition

Ansi/aami He75 2009 Edition Average ratng: 4,0/5 1972 reviews

PROVIDENCE, R.I. & MINNEAPOLIS & ST. PAUL, Minn.--( )--Ximedica, provider of comprehensive product development services to leading medical device makers and healthcare companies today announced the addition of three new members to its Human Factors Team, two of whom have most recently spent time at Medtronic. Says Aidan Petrie, Chief Innovation Officer, “Ximedica continues to see tremendous growth and diversity in its program portfolio as more and more organizations move towards an integrated, user-centric development process.

In support of these programs all of which benefit from the inclusion of human factors early and often through the process we made a strategic decision to add significantly to our Human Factors team, particularly in our Minneapolis office.” Paul Cassidy joins Ximedica as Principal Human Factors Scientist- Minneapolis office. Paul has spent the past 7 years working as a human factors engineer with Medtronic serving in two of their divisions, the Structural Heart Division and Cardiac Rhythm Disease Management Division. Rosana luna nueva rar file.

Contents of ANSI/AAMI HE75:2009 Page Glossary of equivalent standards.xiii.

2009

He has extensive experience generating hardware and software design concepts (physical models and prototypes, graphical user interfaces, and product labels and graphics), as well as designing and conducting formative and summative usability evaluations to enhance product development design as well as fulfill regulatory requirements. During his time with Medtronic he spearheaded HF activities on products including the Medtronic CoreValve transcatheter aortic valve implantation delivery systems, Bio-Console 560 Speed Controller centrifugal blood pump system, a Hemostasis Management System and others. In addition Paul holds patents on multiple delivery system designs and is a contributing author to the HFE section in ISO 5840-3:2013, Cardiovascular implants -- Cardiac valve prostheses -- Part 3: Heart valve substitutes implanted by transcatheter techniques as well as ANSI/AAMI HE75, 2009 Edition - Human factors engineering— Design of medical devices. Paul holds both a Doctorate and Master’s degree in Kinesiology from the University of Minnesota, and a Bachelors in Psychology from the University of Connecticut. He also previously worked at the 3M Company and Exponent, Inc. Rebecca Huebner joins as a Human Factors Engineer- Minneapolis office.

Rebecca’s most recent role was within Medtronic’s Structural Heart Division where she undertook projects including a Heart Valve Human Factors Evaluation and Hemostasis Management System Design. Her contributions on these projects included designing and conducting formative and summative usability evaluations to enhance product development design while fulfilling regulatory requirements. Tatyana Budantsev joins as a Human Factors Engineer-Providence office. Having recently received her Masters of Human Factors in Information Design from Bentley University, Tatyana Budantsev will be based out of Ximedica’s Providence headquarters.

Her studies while at Bentley focused on incorporating qualitative and quantitative user data into product design while also understanding business needs. Prior to returning to school for her masters, Tatyana spent more than 7 years in clinical settings coordinating care and assisting in surgical procedures. Say Petrie, “Increasingly integrating usability into the development process not only helps establish the user needs and design inputs but also helps expedite the program so we are committed to build our HFE (human factors engineering) capability alongside our engineering. We are also finding that understanding hospital and clinical purchasing motivators is increasingly key to defining feature sets and our HF team is critical to answering those questions.” About Ximedica Ximedica is a full service ISO 13485 certified and FDA registered product development firm with an exclusive focus on medical products.

With more than 25 years of experience developing medical devices, combination products and consumer healthcare products our client base spans the globe and ranges from start-ups to the world's largest OEMs.