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Agile Next Steps for Regulated Medical Software

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Location

The Centres at Burlington

67 S. Bedford St.

West Lobby

Burlington, MA 01803

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Refund Policy

Refund Policy

Refunds up to 7 days before event

Eventbrite's fee is nonrefundable.

Event description

Description

Agile Next Steps for Regulated Medical Software

Your company has accepted the concepts of Agile and you’ve started one or more projects which use the approach. You’re making good progress, but you want guidance on getting the most out of this new method. In particular, you’re looking for how to document your project, how to address risk management, how to coordinate hardware and software efforts, and how to work in human factors engineering (none of which classically seems to fit the Agile mindset).

Instructors Nancy Van Schooenderwoert and Brian Shoemaker have presented multiple workshops and courses to medical device audiences since 2009. They combine depth of experience in the Agile and engineering fields: hardware and software development, Agile coaching, regulated software for medical products, software quality, regulatory concerns, documentation, risk management.


Course details

Picking up the thread from the introductory course, this session explores topics essential to any regulated medical product company applying an Agile approach for development. You’ll come away with a deep understanding of ways to avoid the false dichotomies that pit expediency against larger business needs - you’ll see how actions at the team level can improve overall flow of the work, and keep technical complexity from crippling later progress. You will also learn practical ways to address special needs of medical device work (such as documentation, risk management, hardware, or human factors...) without sacrificing any of the benefits Agile brings.

Topics Covered:

  • Lean Flow in a Medical Device Example
  • Handling Complexity
  • Applying Agile Beyond Software
  • Documentation in Agile
  • Risk Management within Agile
  • Where does Human Factors Engineering fit?
  • Agile Leadership and the Organization

Each topic is reinforced through interactive exercises that all attendees can participate in, and most can be brought back to your workplace and used with the rest of your team members.

Our focus is on the core principles and practical ways to use them rather than on any one Agile methodology or framework. Our approach is compatible with Scrum, XP, and other Agile methods, and is based on experience working with a variety of medical device teams.

Who should attend?

  • Regulatory specialists
  • Functional managers - Software, Test, Hardware
  • Product / Project managers
  • Technical leaders
  • Business Analysts, Requirements Analysts

This is an intermediate course, and makes an assumption that attendees have either attended our introductory course, or have been involved in their company’s Agile adoption program for at least 6 months.




Course Instructors

Nancy Van Schooenderwoert

  • 15 y safety-critical embedded systems development experience, as Electronics and Software designer
  • Agile coaching of teams & managers in regulated industries since 2002
  • Industries: Aerospace, Medical Devices, Sonar Weaponry, Scientific Instruments, Industrial Controls, Financial Services
  • Active in Agile New England & Agile Alliance; speaker at Agile-related conferences worldwide

Brian Shoemaker

  • Originally an analytical chemist
  • 15 y in clinical diagnostics: analysis support - assay development - instrument software validation
  • 6 y as SW quality manager (5 in clinical trial related SW)
  • 14 y as independent validation consultant to FDA-regulated companies – mostly medical device
  • Active in: software validation, Part 11 evaluation, software quality systems, auditing, training




Here's what course attendees are saying…

“One of the best courses I’ve been on. Great combination of theory, exercise, and personal accounts…. Brilliant. I now have something to take back to Oxford. Thanks!”

- John Garratt, Analyst, Mirada Medical

“The delivery technique is excellent (e.g. the presentation slides, activities, team discussions, play games, powerful questions, etc.). Thanks.”

- Wenjin Li, Medical Device QA Mgr

“The exercise of moving the tasks from dept to dept and to ‘Ship It’ was a great example and really gave us some ideas we can use to help explain the idea to non-dev management. Plus ... it wakes everyone up.”

- Grayson Marpes, Director, Compliance and Governance, Infor




Course Format - Full Day

  • 8:30 - 9:00 Check-in, coffee and light breakfast
  • 12:00 - 1:00 Lunch break - Selection of items available and included in course fee
  • 5:00 pm - Course complete!

Includes:

  • Lunch, plus morning and afternoon breaks with refreshments
  • Wi Fi connectivity
  • Free parking


Questions?

You can contact us with any further questions you may have.

Email: orderinfo@leanagilepartners.com

Phone: 781 492 5376 (cell)


Cancellation Policy

Cancellation by course organizers would only occur in the unlikely event of insufficient registration. If the course is cancelled, we will notify you no later than Jan 8, 2020, and refund your payment in full. We cannot be responsible for non-refundable travel expenses you incur. If you'd need to travel to attend and are concerned about possible cancellation, please contact us at orderinfo@leanagilepartners.com and we will let you know if we've passed the minimum required attendance.



FAQs


What are my transportation/parking options for getting to and from the event?

The site has a very large outdoor parking lot. Parking is free. The area is best reached by car.

What can I bring into the event?

Your laptop is good to bring although it's not required to participate in the course.

How can I contact the organizer with any questions?

Email: orderinfo@leanagilepartners.com

Phone: 781 492 5376 (cell)

What's the refund policy?

Jan 9, 2020 is the last day to request a refund. You may cancel after that date but no refund can be given.

Cancellation by course organizers would only occur in the unlikely event of insufficient registration. If the course is cancelled, we will notify you no later than Jan 9, 2020, and refund your payment in full. We cannot be responsible for non-refundable travel expenses you incur. If you'd need to travel to attend and are concerned about possible cancellation, please contact us at orderinfo@leanagilepartners.com and we will let you know if we've passed the minimum required attendance.

Do I have to bring my printed ticket to the event?

It is helpful to bring your ticket, but it's ok to have identification that matches the name given when the ticket was bought.


Is my registration fee or ticket transferrable?

Yes, if you tell us in advance. Please use email.

Email: orderinfo@leanagilepartners.com

Is it ok if the name on my ticket or registration doesn't match the person who attends?

Yes, if you tell us in advance. Please use email.

Email: orderinfo@leanagilepartners.com


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Date and Time

Location

The Centres at Burlington

67 S. Bedford St.

West Lobby

Burlington, MA 01803

View Map

Refund Policy

Refunds up to 7 days before event

Eventbrite's fee is nonrefundable.

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