IEC 62304 2nd Edition Status Webinar

Two webinars will be held for the National Committees of IEC/SC 62A and the Member Bodies of ISO/TC 215, Health Informatics, as well as the Member Bodies of ISO/TC 210, Quality management and corresponding general aspects for medical devices. These webinars are being held to explain the status of the IEC 62304 project.
A committee draft for Enquiry Ballot was issued by IEC/SC 62A and ISO/TC 215 for IEC 62304 Ed 2.0 with the deadline of early May 2018. This draft was not approved to go forward and the IEC 62304 revision project team met to resolve the comments received as well as to recommend the next course of action to the officers of the IEC and ISO committees.
Given the nature of the comments, the committee officers have determined that the draft will be revised and circulated as a third Committee Draft later this year. At that time, National Committees/Member Bodies will have a chance to submit comments. The project team has been discussing possible options for the revision of the general requirement of risk management in IEC 62304. The options will be discussed during the Webinar.
The webinars are being held as part of the messaging campaign to alert the National Committee/Member Bodies of the planned action for IEC 62304.
Please note that the webinars will be broadcast on two different days at two different times to accommodate most of the National Committee/Member Bodies at a time that may be more convenient. Please only participate in one as same information will be relayed in both of the webinars (titled Session 1 and Session 2). Please note that this will not be an open discussion session and questions, if any, will be moderated and answered.
The webinars will be open but please remember to register early and to log into the appropriate session: Tuesday, 2 October 2018: 23:00 – 02:00 (UTC) – Session 1
Registration link:
Thursday, 4 October 2018: 12:00 – 15:00 (UTC) – Session 2
Registration link:

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.

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Next public offering:  June 5-7, 2024
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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
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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

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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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