14
Jan
2024

62304/FDA Public Training Course – Boston – June 5-7, 2024

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SoftwareCPR Training

62304 Public Training Course

Course Dates:  June 5-7, 2024 CANCELLED

COST: 3 Full Days for $2,900.00 (50% refundable through January 31, 2024. Fully transferable at any time.)

Limited number of Early Bird discount coupons (worth $895)  available on a first come-first serve basis.  Use coupon code:
(thats three-zero-letter p-letter e-letter r)

Early bird discount available through 1/31/2024.

This 62304 Public Training Course provides a clear understanding of the 62304 standard for medical device software, FDA expectations for software, and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment between them. In addition, participants will learn other standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366). Special update includes SoftwareCPR recommendations for SaMD considering FDA Pre-Cert program!

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Key topics:

  • New FDA premarket submission guidance details and impact
  • Cybersecurity activities aligned with 62304 using IEC 81001-5-1
  • System level risk analysis for SaMD – Software risk management guidance from 80002-1
  • Using 62304 software safety classes to prioritize rigor and documentation
  • New module focused on AI/ML training software & risk management when using ML
  • Discussion of Agile methods throughout the course
  • Understanding Design Input and and the sometimes confusing “left side” of the ‘V’
  • Differentiating unregulated, Class I, and Class II/III software in a single system
  • Software verification, automated testing, test planning
  • Practical, real-world examples and discussion
  • Workshops and exercises integrated throughout teaching modules

This 3 day course will be taught by Brian Pate of SoftwareCPR.

Full credentials on our website:  https://www.softwarecpr.com/consultation/

Who Should Attend this 62304 Public Training Course?

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 Course Location

Boston University, Boston, MA

Morning coffee/refreshments, Hot Lunch, and afternoon snacks/refreshments provided!

 

 

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About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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

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