Topic: What Does it Take to Establish Good Requirements and Specifications? Speaker: Tom Shoup, Foxburg LLC. Following Mike Frazier’s presentation last September on Improving Quality through Effective Product Requirements, this month’s presentation addresses some of the barriers to establishing software requirements and specs and presents some of the sources available to help with basic design documents. These documents include the Software Requirements Specification (SRS), a Software Design Description (SDD), and a Software Design Spec (SDS). Discussion will include why software specifications seem to be more mercurial than hardware specs and system requirements. Examples of key points from the basic documents (SRS, SDD, SDS) will be provided. Tom Shoup is the principal at Foxburg LLC, where he works with companies on their first medical-device, both startup companies and established companies new to the device field. Tom has helped multiple companies learn the engineering operations needed to be a medical-device company, helping them get started with a quality system then often shifting to a technical and operations role. Before starting Foxburg, LLC Tom held various engineering, management, and executive positions at medical-device companies. He started his career at HP in their medical-device business, focused on ultrasonic imaging and patient monitoring. As VP of R&D at subsequent companies, Tom contributed to real-time 3D ultrasonic imaging as well as advances in LASIK eye surgery. As principal scientist at Pelikan Technologies, he contributed to the technical success of an all-in-one glucose meter that including painless lancing and a day’s supply of tests. Since starting Foxburg, Tom has worked on surgical products, multiple IVDs, and other medical devices for companies responding to FDA complaints or learning how to be a medical-device company. Tom has a Ph.D. in physics from Washington University in St. Louis and completed Executive Education for General Managers at the Univ. of Mich. Ross Business School. In 2008 he created Design Control for Medical Devices as a required part of the certificate program at UC Silicon Valley Extension and taught it for six years. In 2017 Tom wrote Premarket Risk Management for New Medical Device Companies, published by the Association for the Advancement of Medical Instrumentation. Tom holds 13 issued patents in medical devices for hardware, software, and signal processing applications. Agenda: 6:30: Introductions and networking 7:00: Speaker topic 8:00: Questions and networking SSQA meetings are held monthly on the second Tuesday of the month. Topics cover all aspects of software quality assurance. Meetings are free and open to the public. Anyone interested in speaking, discussing a topic, or hearing a particular speaker should contact Doug Hoffman ( [masked] ).