Course / Conference suggestions to attend?

[Dobby1979]

Hi Everyone, Happy New Year.

I am looking at some courses / conferences for the upcoming year and was wondering if there are any recommendations from people!

Ideally I would like to attend a course / conference on Risk Management but with a caveat! Risk Management for Software! My google searches are not bringing up anything of interest so was hoping you guys and girls could help with suggestions!

To give some background. I work for a Medical Device Software company that produces software applications for analyzing MRI images.

Any recommendations gratefully received.

Dobby

 

[randomname]

Check out this website/individual: http://softrel.com/

Here's an upcoming workshop by her: http://www.softrel.com/5SWFMEATraining.html

 

[Ajit Basrur]

This one too :

http://www.complianceonline.com/medical-device-software-risk-analysis-webinar-training-700902-prdw

Disclaimer: I have no connection with complianceonline.

 

[tantepetunia]

Hi Folks,

Does someone know good courses on this subject, risk analysis for Softwars as a medical Device? The previous answer given in this thread was a litle bit old, and the ISO changed. (2017)


Thanks a lot!

 

[Miner]

A quick search found these as well as more I did not list.

• Risk Management For Medical Device by ASQ
• ISO 14971 Medical Device Risk Management Training by Stat A Matrix

 

[yodon]

There's not a whole lot that I know of for risk management specific to a SAMD. ANSI/AAMI/IEC 62304:2006 with the 2015 amendments gives some structure. ISO 14971:2019 and the associated TR 29471:2020 (neither harmonized yet) provide the overall structure.

IMDRF has posted some material that might be useful.

It should be noted that there are some good discussions in progress in the Cove here on integrating cybersecurity risk management under 14971. Cybersecurity risk management is definitely something you'll need to address.