Agile Quality Systems

Medical Software Development Essentials

23 January 2018

Developing software in compliance with the FDA Design Control regulations and international standards is challenging. 

This one-day course provides background and suggestions for developing software in a manner that meets applicable FDA guidance documents and international standards, such as IEC 62304. 

Topics include: 
a. Software Planning / Classification
b. Software Requirements / Traceability
c. Risk Management
d. Design Reviews
e. Software Testing (unit level, integration, design verification)

Register Here.

INCOSE Conference on Agile Systems in Health Care

19-20 April 2017  Minneapolis MN

The Application of Agile to the Development of Medical Device Systems

September 22-23, 2016  Arlington VA

See more at AAMI Events.

Effective Application of Agile Practices in the Development of Medical Device Software

October 31 - November 1, 2016  San Diego CA

North Star Chapter of INCOSE Fall Tutorial 
Can Agile and Systems Engineering Work Together?

November 4, 2016   Minneapolis MN

Topics Include:

• Lean and Agile Principles Applied to Systems Development
• Barriers and Benefits to Adopting Agile
• Architecture of Agile Teams, and the roles of Systems Engineering
• Product Development Processes in an Agile Model
• Beyond software:  Tailoring Agile Software Practices for Hardware and Systems

Email registration form available here.

INCOSE Conference on Agile Systems in Health Care

May 23-24, 2016  Schaumburg IL

The Health Care Working Group of the International Council on Systems Engineering (INCOSE), with support from the INCOSE Agile Systems Working Group and System Patterns Working Group present “INCOSE Conference on Agile Systems in Health Care”

The overall system and system components of Health Care (including its delivery processes, pharmaceuticals and other therapies and preventive measures, medical devices, and its regulatory and economic framework) are challenged to be "agile systems". Agility challenges arise from shifting threats, expectations, and competition, advances in technology and medical science, and evolving economic and regulatory aspects. 

Although the software development community has advanced the practice of agile development of software, the system-level opportunities and challenges of agility are much broader than software alone. This conference is about the current landscape, examples of progress in agility for more general systems, and the road ahead. It builds on an earlier conference held in 2015.  This two-day conference includes multiple session learning tracks as well as collaboration session opportunities to advance the state of the community. Watch this space for future posting of the detailed schedule of tracks, topics, and sessions.

The conference is will be May 23-24, 2016 8:30 AM - 5:00 PM (CDT), in Schaumburg, IL (Chicago region.

Thanks to the conference organizers and sponsors, the registration fee for this event is a modest $100, for the full two-day event, including lunches and refreshments. (Each speaker presenting at the conference will be granted a free registration ticket.) However, meeting size is limited and you must register in advance to attend…see the site for more //www.eventbrite.com/e/incose-conference-on-agile-systems-in-health-care-tickets-21830838626

We look forward to seeing you there!

Agile for System Development - TwinSPIN Presentation

March 10, 2016  Minneapolis, MN

Presentation Slides, click here.

Agile Software Development is not just for software, because software development is usually not only about software engineering. Embedded software teams have long had to work different engineering disciplines within the context of a system development model. And now, traditional “software-only” applications like internal IT systems, banking systems, retail software, etc., are big systems that need more than software engineering, they also need concepts and methods of systems engineering. The Agile community recognizes this, and one of the popular Agile scaling frameworks, “SAFe”, created by Scaled Agile Inc., embraced systems engineering concepts in their recent update to “SAFe 4.0 for Lean Software and Systems Engineering”. Long-established Systems Engineering process models, such as those developed by INCOSE and NASA, can be applied within the context of a scaled Agile development framework, getting the benefits from a robust process model and the benefits of Agility. This session will explore this combination. As usual for TwinSPIN, this session counts on interaction with the audience, so please come ready to think about your software/systems development context and ask questions and offer insights into how Agile & Systems Engineering applies, or could apply, to you.

See more events at TwinSPIN.

Agile Software Development for FDA-Regulated Medical Device Applications

R&D Workshop: Agile Software Development for FDA-Regulated Medical Device Applications

Sept 17, 2015  Boulder, CO

Effective Application of Agile Practices in the Development of Medical Device Software

October 6-7, 2015  Arlington VA