October 2018: Agile for Safety-Critical Systems: A Process for Safety and Quality in Medical Devices

Live Feed: A link to a live feed to join the meeting via Google Hangouts will be posted here.
Speaker: Brian Shoemaker
Date: Thursday, October 18, 2018
Agenda: 6:00-6:45 Networking
6:45-7:00 Opening Announcements
7:00-8:20 Featured Presentation
8:20-8:30 Closing Announcements
Who’s Invited: Everyone (industry, government, academia)
Location: !!! Note New Location !!!
Boston University, Room FLR 109
808 Commonwealth Avenue
Boston, MA
Location details: We will meet in Room FLR 109, on the first floor of 808 Comm Ave in the building on the corner of Comm Ave and Essex St.Enter on the Essex St side of the building.

Public parking and Green Line B (BU West stop) are nearby.

See Meetup.com images for details.

More Info: For SPIN info, contact the SPIN Chairperson.
Boston SPIN meetings are free. RSVP at Meetup or by email to bostonspin01@gmail.com is preferred.
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Featured Presentation: Agile for Safety-Critical Systems: A Process for Safety and Quality in Medical Devices

Speaker: Dr. Brian Shoemaker, ShoeBar Associates, Co-Author of ‘Agile Methods for Safety-Critical Systems: A Primer Using Medical Device Examples’

In their recent book, co-authors Brian Shoemaker and Nancy Van Schooenderwoert review the basic principles of Agile to show how to apply these principles in a safety-critical context such as medical devices.

In his talk, Brian will explain how the philosophy of Agile is consistent with, and beneficial for, the regulatory requirements of safety-critical development. He will also expand on the guidance provided in the AAMI TIR 45 technical report on the use of Agile for medical device hardware and software.

Brian Shoemaker, Ph.D. is Principal Consultant at ShoeBar Associates.  He has more than 20 years of experience with software quality and validation in the FDA-regulated industry, and in diverse application areas, including automated in vitro diagnostics, clinical trial data management, clinical safety data, ERP and shop floor automation, change order management, and electronic document management. He is well versed in practical application of FDA and ISO requirements for software life cycle documentation, validation, and risk management, and is adept at unraveling issues around electronic records and signatures (21 CFR Part 11).