This 2-part webinar explains ISO/TR 24971:2020, the guidance document for the application of ISO 14971:2019, the risk management standard.
The previous version of this webinar was recorded on February 10, 2020. That webinar reviewed the draft version of the ISO/TR 24971 guidance document that was available as a pre-order from AAMI. The final version of the guidance is now available at a lower cost from Estonia Centre for Standardisation and Accreditation. We are now expanding and updating the webinar into a two-part webinar. Part 1 of this webinar will be presented live on Tuesday, April 12 @ 9-10:30 am EDT. Part 2 of this webinar series will be presented live on Tuesday, April 19 at 9-10:30 am EDT. Purchase of this webinar series will grant the customer access to both live webinars. They will also receive the native slide decks and recording for the two webinars.
What’s new in our 2-part live webinar on ISO/TR 24971:2020?
The previous version of this webinar did not cover all of the Annexes in depth due ot lack of time. The previous version provided an overview of the guidance document, explained how to perform software hazard identification, and provided an emphasis risks releated to security (i.e. Annex F). This new expanded and updated webinar will review all of the Annexes of ISO/TR 24971:2020. This will include the following:
Part 1 of 2 – Scheduled for April 12, 2022 @ 9-10:30 EDT
- Highlights of information provided in Sections 1-10 of the guidance that helps to explain ISO 14971:2019 (formerly Annex D of ISO 14971:2007)
- Annex A – Identification of hazards and characteristics related to safety (formerly Annex C of ISO 14971:2007)
- Annex B – Techniques that support risk analysis (formerly Annex G of ISO 14971:2007)
- Annex C – Relationship between policy, criteria for risk acceptability, risk control and risk evaluation (NEW)
Part 2 of 2 – Scheduled for April 19, 2022 @ 9-10:30 EDT
- Annex D – Information for safety and information on residual risk (formerly Annex J of ISO 14971:2007)
- Annex E – Role of international standards in risk management (NEW)
- Annex F – Guidance on risks related to security (NEW)
- Annex G – Components and devices designed without ISO 14971 (NEW)
- Annex H – Guidance on in vitro diagnostic (IVD) medical devices (formerly Annex H of ISO 14971:2007)
Register for the expanded and updated, 2-part live webinar on ISO/TR 24971:2020 for $129
Two-part Webinar on ISO/TR 24971:2020 – Part 1 of this webinar will be presented live on Tuesday, April 12 @ 9-10:30 am EDT. Part 2 of this webinar series will be presented live on Tuesday, April 19 at 9-10:30 am EDT. Purchase of this webinar series will grant the customer access to both live webinars. They will also receive the native slide decks and recording for the two webinars.
ISO 14971:2019, Risk management standard for medical devices
On December 17, 2019 we posted a new blog about the ISO 14971:2019 standard. We made additional updates to the risk management procedure (SYS-010) to include references to the 2019 version of ISO 14971 and Regulation (EU) 2017/745. We updated our risk management training webinar to the 2019 version based upon the 2018 draft that was released, but additional updates will be included in the 2022 expanded 2-part webinar scheduled for March 29, 2022 and April 5, 2022.