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:

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

for more info!

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