News & Events

Upcoming Events

Date Event Location Description
7 June 2013

XP 2013 Conference (13th Annual)

Vienna, Austria

"Fast Can be Safe: Coaching Agile Medical Software Development"

A live tutorial in Medical Software Development using Lean/Agile Methodologies

When: Friday, 7 June 2013, 09:00

Location: NH Danube City Hotel, Vienna, Austria

Instructors: Nancy Van Schooenderwoert and Brian Shoemaker

This workshop focuses on the intersection of Agile practices and the realities of safety-critical, regulated product development. There is no contradiction between being fully Agile and fully compliant with all the medical regulatory requirements in the USA (FDA) or in Europe (IEC). The focus is on medical product development, but the concepts behind those regulations apply to other safety-critical industries as well.

This is a version of the course "Agile 4 FDA: The Lean-Agile Solution", but with a focus on what Agile coaches need to know when they are working with medical development teams.

Previous 2013 Events

Date Event Location Description
17 May 2013

Agile 4 FDA

Burlington, MA, USA

"Agile 4 FDA: The Lean-Agile Solution"

A live workshop in Medical Software Development using Lean/Agile Methodologies

When: Friday, 17 May 2013

Location: The Centres at Burlington, 67 S. Bedford Street, Burlington, Massachusetts

Instructors: Nancy Van Schooenderwoert and Brian Shoemaker

This full-day course provides an introduction to both Lean and Agile practices for companies building medical products covered by FDA regulations. Brian Shoemaker and Nancy Van Schooenderwoert present fundamentals of software quality for FDA compliance— with lean and agile principles to resolve quality/safety versus cost/time.

8 April 2013

Improving Existing Java Code

Burlington, MA, USA

"Improving Existing Java Code", with Llewellyn Falco

A hands-on workshop in Refactoring and Emergent Design in Agile Software

When: Friday, 8 April 2013

Location: The Centres at Burlington, 67 S. Bedford Street, Burlington, Massachusetts

Instructor: Llewellyn Falco

Many companies have vast amounts of pre-existing, valuable code in production. Unfortunately, this code might be brittle, confusing, or otherwise hard to maintain. In many companies, this situation continues to degrade until a team tries to do a rewrite to replace the outdated system. Worst of all, most of these expensive attempts end in failure.

There is another way. This course is about how to work with your existing code, how to get it under control, and how to clean and improve it steadily while fixing bugs and adding needed features. With these disciplines and techniques, your codebase will, over time, come to look as if it had been completely rewritten.

19 February 2013

Software Quality and FDA

Burlington, MA, USA

"Software Quality and FDA: The Lean-Agile Way"

A live workshop in Medical Software Development using Lean/Agile Methodologies

When: Tuesday, 19 February 2013: 8:30 AM to 5:30 PM (Eastern Time)

Location: The Centres at Burlington, 67 S. Bedford Street, Burlington, Massachusetts

Instructors: Nancy Van Schooenderwoert and Brian Shoemaker

This full-day course provides an introduction to both Lean and Agile practices for companies building medical products covered by FDA regulations. Brian Shoemaker and Nancy Van Schooenderwoert present fundamentals of software quality for FDA compliance— with lean and agile principles to resolve quality/safety versus cost/time.

(This is the same course as the full-day tutorial we presented at the SDMD Europe 2013 Conference in Munich, except that the focus in Europe is on European standards rather than those of the FDA.)

29-31 January 2013

SDMD Europe 2013

Munich, Germany

"SDMD Europe 2013 Conference"

When: Tuesday, 29 January 2013 through Thursday, 31 January 2013

Location: Eden Hotel Wolff, Arnulfstrasse 4, 80335 Munich, Germany

Instructors: Nancy Van Schooenderwoert and Brian Shoemaker

Nancy Van Schooenderwoert and Brian Shoemaker will participate in several sessions, and also present a full-day tutorial:

  • 29 January: Brian Shoemaker is a panelist for discussion, "Software Lifecycle Processes - IEC 62304".
  • 29 January: Brian Shoemaker presents "Onward to Approval: Documenting Development for Regulatory Compliance".
  • 30 January: Nancy Van Schooenderwoert presents "No Bugs: Using Agile Methods for Safety-Critical Applications".
  • 31 January: Nancy Van Schooenderwoert and Brian Shoemaker present a full-day tutorial, "Introduction to Agile Methods for European Medical Product Software Development", with specific reference to IEC 62304, ISO 14971, ISO 13485.