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News & Events

Upcoming Events

Date Event Location Description
30 October - 1 November 2013

Agile Medical Device Development

Hørsholm, Denmark

"Agile Medical Device Development", a 3-day course presented in cooperation with Delta

Location: DELTA Hørsholm, Venlighedsvej 4, 2970 Hørsholm, Denmark

Instructors: Nancy Van Schooenderwoert and Brian Shoemaker

This 3-day course focuses on the intersection of Agile practices and the realities of safety-critical medical product development. There is no contradiction between being fully Agile and fully compliant with all the medical regulatory requirements in the US and EU.

Further details and registration at:

18 - 20 November 2013

Agile Medical Device Development with Microsoft Team Foundation Server

Zürich, Switzerland

"Agile Medical Device Development with Microsoft Team Foundation Server: Compliance with Shorter Time-to-Market", a 3-day course presented in cooperation with Tech Talk

Location: Microsoft office in Zürich, Switzerland at Richtistrasse 3, 8304 Wallisellen

Instructors: Nancy Van Schooenderwoert, Brian Shoemaker, and Christian Hassa

This 3-day course focuses on the intersection of Agile practices and the realities of safety-critical medical product development. There is no contradiction between being fully Agile and fully compliant with all the medical regulatory requirements in the US and EU.

Further details and registration at:

Previous 2013 Events

Date Event Location Description
17 September 2013

Webinar:
Agile Medical Device Development with Microsoft Team Foundation Server

Online

Webinar: "Agile Medical Device Development"

Location: Online, No Charge!

Time: 17:00 (Central European Time)

Instructors: Nancy Van Schooenderwoert, Brian Shoemaker, and Christian Hassa

Experts Nancy Van Schooenderwoert, Brian Shoemaker, and Christian Hass will show how agile development can support quality management systems for designing and building medical products better than you might expect.

Learn how agile methods and suitable tools on the Microsoft platform allow for a more effective medical product development.

The webinar is designed to serve companies that develop medical devices, medical diagnostic systems, clinical trial data management and safety-Data software, or any other software used in products that diagnose or treat disease.

Support of the presented methods and practices with tools will be demonstrated using Microsoft Team Foundation Server, SpecFlow, and SpecLog.

The Webinar will be held in English, however, there will be the possibility to ask questions in German during the Q&A session at the end.

Register at:

3 September 2013

Webinar:
Agile Medical Device Development

Online

Webinar: "Agile Medical Device Development"

Location: Online

Time: 15:00 (Central European Time)

Instructors: Nancy Van Schooenderwoert and Brian Shoemaker

Experts Nancy Van Schooenderwoert and Brian Shoemaker will show how agile development can support quality management systems for designing and building medical products better than you might expect.

If you develop medical devices, medical diagnostic systems, clinical trial data management systems, or any other software used in products that diagnose or treat disease, this webinar is for you.

Register at:

8 August 2013

Agile 2013 Conference

Nashville, Tennessee

"Evolving Agile Contracts Through Validated Learning"

When: Thursday, 8 August 2013, 9:00 AM - 10:15 AM (Eastern Time)

Location: The Gaylord Opryland Hotel & Convention Center, 2800 Opryland Drive, Nashville, Tennessee 37214

Speakers: Nancy Van Schooenderwoert and Steve Holyer

Issues with contracts and Agile teams are tightly bound up with their context— with the people, the risks, the trust levels existing between the entities. Rather than try to understand contracting from the top down or from the general to the specific, we are starting with "live ones"— real life situations happening now.

This session takes you along as we discuss what happened with our first encounter with a "live one", what we discovered, and what resulted from our advice and experiments with the contract.

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.

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.