1st quarter 2025 Agile & Compliant courses scheduled

Developing safe and effective medical device software is not easy.

Doing that efficiently AND meeting regulatory compliance requirements is even harder.

Many companies are implementing agile or lean software development methods to improve results.

But can those methods also be compliant at the same time?

Yes!

There is a caveat, however … agile approaches “out of the box” won’t be compliant. There are some adjustments needed.

The good news is that the adjustments – if integrated into the agile approach – won’t destroy all the agile/lean benefits like many believe.

Learn how to do so in SoftwareCPR’s courses, as others have done for more than a decade.

Learn how at these upcoming courses:

Here are the upcoming 3-day virtual public offerings, scheduled for different time zone needs (time zone examples listed for each course):

  • Americas: 11-13 February 2025 each day at:
    • 1400-1800 eastern South America
    • 1300-1700 Atlantic and South America
    • noon-4p Eastern time, Panama, and South America
    • 11a to 3p Central time
    • 10a to 2p Mountain time
    • 9a to 1p Pacific time
  • EU/Eastern Europe/Middle East/Africa/Atlantic/eastern South America: 18-20 February 2025 each day at:
    • 1400-1800 EET
    • 1300-1700 CET
    • 1200-1600 GMT
    • 0900-1300 eastern South America
    • 0800-1200 Atlantic time and South America
  • Southern/central/northeastern Pacific: 24-26 February 2025 each day at:
    • 1p-5p Pacific time
    • Noon-4p Alaska
    • 11a-3p Hawaii
    • 10a-2p New Zealand (25-27 February)
    • 8a-noon Eastern Australia (25-27 February)

Sign up for whatever course meets you timing needs, even if you are in a different region.

Pricing information and FAQs:

  • What is the course fee?
    The course is US$1,520.
  • Is there an early registration discount?
    YES! Early registrations get 25% off and pay only US$1,140.
  • Are there any other early registration benefits?
    Yes! Those who register early also get a US$500 discount coupon that can be used for our Next Level Workshop when held onsite. The workshop is a fully hands-on, backlog driven process improvement team workout led by SoftwareCPR consultants.
  • What are the early registration deadlines?
    • Americas: 14 January 2025
    • EU et al: 21 January 2025
    • Pacific: 28 January 2025
  • What if I need to cancel?
    You may cancel anytime before the early registration deadline and get a refund of the course fee.
    You may also transfer your registration to another person anytime up until 1 hour before the course begins.
  • What if the course is cancelled?
    If SoftwareCPR cancels the course after the early registration deadline, you may transfer your registration to a different course or get a full refund of registration fees, including reimbursement for any credit card fees paid.
  • What if the course is rescheduled?
    If SoftwareCPR moves the course date, you will have three options.

    • You can transfer your registration to another person.
    • You can ask for a registration transfer to another course.
    • You can get a full refund of registration fees minus any credit card fees.
  • Will we get the course materials?
    Yes. Participants will get PDFs of any course slides and materials presented during the course.
  • Are these courses virtual?
    Yes. Courses will be conducted via Zoom.
  • In what language will the course be conducted?
    English.
  • Is there a limit to the number of participants in a course?
    Yes, we limit attendance to allow interaction and sharing.
    We may accommodate larger groups in private sessions.

To register and secure your place, use the form below.

 

Want the training sooner, for your entire team, or at different times? We provide private versions and tailored workshops … email us at training@softwarecpr.com to discuss.

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:

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

 

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:  TBD

Call or email now to schedule a private, in-house class. The fall schedule is filling up!

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

TBD

 


 

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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