62304/FDA Public Training Course – Virtual

IEC 62304 and Emerging Standards for Medical Device and Health IT Software

DATES:  Oct 19-21, 2021

Clock time each day:  8:30 am – 4:30 pm US Pacific

COST: 3 Full Days for $2,100.00 (Early Bird discount: $1595 thru September 1, 2021)
Special FDA / Government rate:  $500 (contact us at training@softwarecpr.com to qualify)

Multi-student discounts available.

Register at EventZilla: https://events.eventzilla.net/e/sep-2021-softwarecpr–iec-62304-and-emerging-standards-and-fda-expectations-for-medical-device-and-health-it-software-2138808579

Refunds (minus credit card fees) through September 1, 2021.  However, substitutions are allowed up until the day before the course starts.

This 62304 Public Training Course provides a clear understanding of the 62304 standard for medical device software, including FDA expectations for software and alignment with 62304, 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:

  • Applying risk management to software including guidance from 80002-1
  • Amendment 1 changes to 62304 (changes to risk and dealing with legacy software)
  • Using Agile methods for medical device and HealthIT software – while remaining compliant!
  • Using software safety classes to prioritize rigor and documentation
  • IEC 82304 for Health IT and standalone software
  • Cybersecurity planning, evaluation, and validation
  • IEC 62366-1 formative and summative usability/human factors for validation

Plus this bonus material:

  • Update on emerging standards impacting medical device and HealthIT software
  • Discussion on how privacy requirements (e.g., HIPAA) might intersect with risk management activities and cybersecurity procedures
  • Other relevant medical standards for networking safety
  • Workshops and exercises integrated throughout teaching modules

This 3 day course will be taught by Brian Pate of SoftwareCPR using Zoom virtual meeting (or similar virtual method).

Course Flyer:  2021 SoftwareCPR 62304 Course-One Page Flyer-Virtual-r1

Looking for Quality System Software (CSV, production/manufacturing, tools, etc.)  Training?  See our other SoftwareCPR courses at this https://www.softwarecpr.com/training/.

Full credentials on our website: www.softwarecpr.com

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.

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:  June 5-7, 2024
Boston, MA

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

Registration Link:

Register Now

 


 

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: February 12-15, 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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