ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective
Public Training Course DATES: Jan 9-11, 2023
Includes “how to” for application of IEC 62304 for software risk management!
COST: 3 Full Days for $2,995
3 or more students from same company: 10% discount (off full registration)
November 2022 Early Registration: $2,395
Come to sunny Tampa, Florida in January 2023 for our newly updated “ISO 14971 Medical Device Risk Management, A Software Organization’s Perspective” 3-day training course.
This course takes a deep dive into ISO 14971:2019 so that people responsible for SaMD can develop and deepen their understanding of the device level, or product level, risk management requirements. We have found over the years that many of our clients struggled with software risk management because they did not fully embrace device level risk management. This course gives the students a full understanding of ISO 14971 and then explains how cybersecurity, usability, and software risk analyses feed into the device level risk analysis. The course follows the typical process (or processes) introduced by ISO 14971 and IEC 62304, and integrates IEC/TR 80002-1 as a valuable resource for software risk management.
- Regulatory and Standards Background
- Intended use / harm
- System Level Hazard Analysis
- Detailed Risk Analysis Methods
- Use Error Hazard Analysis
- Cybersecurity Threat Analysis
- Software Hazard Analysis
- Risk Estimation
- Risk Control
- Risk Evaluation and Residual Risk
- Production and Post Market Risk Management
- Planning & Documentation
Who Should Attend?
- System Engineering
- Software Engineering
- Quality Assurance
- Regulatory Affairs
- Product Owners
- Scrum Masters/Coaches
- Software development management
- Test management/engineering
This 3 day course will be taught by Brian Pate of SoftwareCPR and Dr Peter Rech of SoftwareCPR. You can download credentials sheets on our Meet Our Team page (https://www.softwarecpr.com/consultation/).
Full credentials on our website: www.softwarecpr.com
Training Course Location
Center for Advanced Medical Learning and Simulation (CAMLS)
124 S Franklin St, Tampa, FL 33602
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Oak and Ola, located in the newly renovated, historic Armatureworks, is a stand-alone restaurant featuring the culinary stylings of James Beard Award-Winning Chef Anne Kearney. (https://www.oakandola.com/home)
The Hyatt Place/Hyatt House in downtown Tampa is conveniently located just 0.3 miles from CAMLS. The Hyatt “infuses its modern chic designs with Tampa’s rich Latin History.” Enjoy stunning city views from the outdoor swimming pool located on the 5th floor deck or start your day with a workout session on one of the Peloton Bikes in the Fitness Center. Many excellent restaurants are located within easy walking distance, or by trolley or water taxi. Several onsite restaurant/beverage venues include the Corazon Bar/Restaurant, Wicked Pour Tap House, Junmai Station Sushi, and a full Starbucks Café on premises.
You can obtain special CAMLS Hyatt hotel pricing at this website:
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