27
Jan
2025

Better medical device software by doing less

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Improving medical device software development isn’t just about adding or modifying.

The simplest approach is to NOT do things that don’t need doing.

This is a key theme we cover in our training and consulting.

“Faster, better, cheaper” is easier to attain when you do less and reduce complexity. The same applies to safety and security.

Find out how to do that and still achieve regulatory compliance in our upcoming Being Agile and Compliant courses.

The first is 11-13 February and time-zone friendly for the Americas.

EU and Pacific time-zone friendly courses follow 18-20 February and 24-26 February (25-27 February Australia and New Zealand).

Discounts are still available. The third and additional attendees from the same organization may register anytime for 25% off.

Get more information, schedules, FAQs, and the registration form at https://www.softwarecpr.com/2025/01/1st-quarter-2025-agile-compliant-courses-scheduled/

About the author

Succeeding despite relentless change is the goal of 21st century organizations. Mike helps achieve those successes by working with leaders of start-ups to Fortune 20 companies and national governments. His aim is to help them re-imagine and create adaptive, innovative enterprises that increase profitability and value across the quadruple bottom line: customers, employees, owners/shareholders, and communities.

SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  June 24-26, 2025 (Boston, MA)

Multiple participants from the same company: If you register 5 or more from the same company before March 15, 2025, receive a special discounted registration of $1999 per person.  These registrations may be transferred to another person at any time. Email training@softwarecpr.com to register and secure the TEAM discount.

 

For private, in-house courses, please contact us.

Email training@softwarecpr.com for more info.

 

 

Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offerings:

  • Americas: 11-13 February 2025
  • EU/Eastern Europe/Middle East/Africa/Atlantic/eastern South America: 18-20 February 2025
  • Southern Central Northeastern Pacific: 24-26 February 2025
See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

 

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

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