Listed below are conferences and public courses related to FDA software regulation and validation that have come to our attention. Inclusion on this list does not imply any evaluation, endorsement, or recommendation by SoftwareCPR. Events at which SoftwareCPR® partners are speaking or instructing are indicated with an * asterisk.
Scroll down the list which is in chronological order.
Click FDA CDRH Workshops for FDA's device center list.
|9/24/2018||The MedTech Conference, Sep 24-26, 2018|
|Philadelphia, PA Featuressenoior level politicians and executives, a wide array of educational programming. For more information click the link provided.|
|9/26/2018||FDA CBER Secure Email Webinar|
|FDA's biologics divsion is holding a webinar regarding setting up a secure email account. CBER will be only use secure email for outgoing regulatory communications. Full information about the webinar is at the link provided.|
|10/1/2018||RAPS Regulatory Convergence, Oct 1-4, 2018|
|Vancouver, BC Canada . Focused on global regulatory affairs and harmonization. For more information click the link provided.|
|10/2/2018||IEC 62304 Edition 2 Issues 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: https://attendee.gotowebinar.com/register/4149891528018705921
Thursday, 4 October 2018: 12:00 – 15:00 (UTC) – Session 2
Registration link: https://attendee.gotowebinar.com/register/5783877957079945729
|10/15/2018||AAMI FDA Agile Methods Compliance Course*|
|Effective Application of Agile Practices in the Development of Medical Device Software - AAMI course Las Vegas, NV Oct 15-16, 2018. Brian Pate of SoftwareCPR will be instructiong. For more information leave a message on our site or email firstname.lastname@example.org.|
|11/6/2018||High Integrity Software Conference, Nov 6, 2018|
|Bristol, UK. Now in its fifth year, the mission of the High Integrity Software conference is to share challenges, best practice and experience between software engineering practitioners. The conference features talks from industrial and academic specialists which disseminate experience and knowledge of important techniques and methods that are applicable across industry sectors. For more information click the link provided.|
|11/12/2018||Medica, Nov 12-15, 2018|
Largest medical trade fair in the world. Each year, leading individuals from the fields of business, research, and politics attend this top-class event.. For more information click the link provided.