04
Apr
2022

Being Agile and Yet Compliant Training Course – May 2022

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New Date!

COURSE DATES: May 9 – 12, 2022 (16 hours of training)
HOURS:  11 am until 3 pm EDT each day
TRAINING LOCATION: Virtual – live online

COST: 4 half days for $1,920 per person

Registration Link:  https://events.eventzilla.net/e/2022-softwarecpr-agile-and-compliant-training-course-2138816565

Only a limited number of discounted seats are available.  For more information on the course, use the form below.

  • Our course is framed around IEC 62304 and how the standard can be used to ensure agile methods and approaches to software development.
  • Discuss the proper activities and deliverables for safe and effective software.
  • Uses concepts from AAMI TIR45 as well to help communicate how agile methods can, when used properly, improve software quality.
  • Reference US regulations and FDA guidance to address potential gaps that can occur with some agile approaches.
  • Understand how backlog management, development iterations, and release cycles can easily align with the intent and expectations of regulators and auditors.
  • Discussion on tools and the very important role they MUST play in the effective use of agile methods for medical device and digital health software.
  • Integrated exercises designed to apply learning!

This 16 hour course will be taught by Mike Russell and Ron Baerg of SoftwareCPR®.

Mike was a member of the AAMI working group that developed TIR45 Effective Application of Agile Practices in the Development of Medical Device Software.  Ron is a current member of the AAMI working group working on the 2nd edition of TIR 45. Full credentials on our website: www.softwarecpr.com

Who Should Attend?

  • Quality Assurance and Regulatory Affairs professionals
  • Product Owners
  • Scrum Masters/Coaches
  • Software development managers and engineers
  • Risk management owners
  • Test engineers

This course will provide a clear understanding of requirements versus areas of flexibility and provide ideas and suggestions to use for gap analysis, auditing, and software vendor and OEM qualification and management as well as improving articulation and defense of your approaches to regulatory bodies, internal quality assurance, and regulatory affairs departments.

Training Location

Virtual course delivered by Zoom.

For more information

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 offering: Dec 3, 4, & 5, 2024 – 12:00 pm to 5:00 pm CET

Register Now

 

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

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
office@softwarecpr.com
Partners located in the US (CA, FL, MA, MN, TX) and Canada.