Being Agile … & Compliant – Feb 18-19, 2019 Public Training Course

COURSE DATES: February 18 – 19, 2019
TRAINING LOCATION: Tampa, Florida, USA

COST: 2 Full Days for $2,495.00
January Registration Discount of 10% available through Jan 19, 2019. Extended to 1/25/2019.

Ask about our multi-student discount as well!

Meet our newest partner, John Murray, at the course!

Download registration form

Only a limited number of discounted seats are available – download registration form and email to training@softwarecpr.com.  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 2 day course will be taught by Brian Pate and Ron Baerg of SoftwareCPR®.

Brian was a member of the AAMI working groups that developed TIR32 Medical Device Software Risk Management and TIR45 Effective Application of Agile Practices in the Development of Medical Device Software. Brian currently is the lead faculty for the AAMI Regulatory Requirements for Software Validation course and is co-faculty for the AAMI Agile course. Ron has over 23 years in developing medical device software for many levels of safety risk. Full credentials on our website: www.softwarecpr.com

Who Should Attend?

Quality Assurance and Regulatory Affairs professionals. This course will provide a clear understanding of requirements versus areas of flexibility and provide checklists and questions to use for gap analysis, auditing, and vendor and OEM qualification and management.
Product Owners, Scrum Masters/Coaches, software development managers/engineers, risk management, and test engineers. This course provides examples, checklists, and partial templates as well as improving articulation and defense of your approaches to regulatory bodies, internal quality assurance, and regulatory affairs departments.

Training Location

Center for Advanced Medical Learning and Simulation (CAMLS). As one of the world’s largest, free-standing centers fully dedicated to training healthcare professionals, the 90,000-square-foot, three-story facility provides a state-of-the-art, clinical environment with 60,000 square feet dedicated to surgical skills labs, operating suites, a virtual hospital and simulation center, and more than 25,000 square feet of dedicated education and conference space. Conveniently located in the heart of downtown Tampa, FL, it is open 7 days a week to accommodate the numerous demands that challenge today’s healthcare providers and researchers as well as its numerous international clients.

Several hotels are within 1 or 2 city blocks of CAMLS. No rental car is needed as many restaurants, shopping and entertainment are easily accessible in the Tampa Riverwalk and Channelside district.

For more information

About the author

Brian is a biomedical software engineer - whatever that is! Started writing machine code for the Intel 8080 in 1983. Still enjoys designing and developing code. But probably enjoys his garden more now and watching plants grow ... and grandkids grow!

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:  TBD

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

Registration Link:

TBD

 


 

Being Agile & Yet Compliant (Public or Private)

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

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

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

Registration Link:

Register Now

 


 

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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