62304/FDA Public Training Course – Virtual – June 6-10, 2022

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

DATES:  June 6-10, 2022 (New date)

Clock time each day:  10 am – 3 pm US EDT (one hour break from 12:00 pm to 1:00 pm US Eastern time)

COST: 5 short days for $2,200.00 – Multi-student discount available for 3 or more students

Early Bird discount! $1995 thru March 11, 2022

Register at EventZilla:  https://events.eventzilla.net/e/april-2022-softwarecpr–iec-62304-and-emerging-standards-and-fda-expectations-for-medical-device-and-health-it-software-2138818552

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, both SiMD and SaMD, including guidance from 80002-1
    • Other hazards analyses impact to software:  usability, cybersecurity, interoperability
  • Amendment 1 changes to 62304 (changes to risk and dealing with legacy software)
  • Understanding how Design Input related to IEC 62304 software requirements
  • 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
  • Workshops and exercises integrated throughout teaching modules

This 5 day course will be taught by Brian Pate of SoftwareCPR using Zoom virtual meeting (or similar virtual method).

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.

Registration

Click here to register and reserve your seat for the course: https://events.eventzilla.net/e/april-2022-softwarecpr–iec-62304-and-emerging-standards-and-fda-expectations-for-medical-device-and-health-it-software-2138818552

Note: Students required to use camera at many points during the training. No recording allowed. Refunds for Full Registration, minus credit card fees, through March 8, 2022. Only substitutions allowed after that. For registrations of 3 or more, get a $250 per student discount.

NO REFUNDS for early bird registration – only substitutions. Early bird discount does not combine with group discount.

Upcoming SoftwareCPR Training Courses:

Public Course – Oct 18-21, 2022 – Being Agile & Yet Compliant (virtual)

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

Register here: https://events.eventzilla.net/e/october-2022-softwarecpr-agile-and-compliant-training-course-2138573767

 

Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

Register here: https://events.eventzilla.net/e/2023-softwarecpr-public-training-course–iso-14971-medical-device-risk-management-a-software-organizations-perspective-2138576610

 

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