FDAnews Announces — Medical Device Software and Risk Management Webinar, Sept. 19, 2018
FALLS CHURCH, Va. (PRWEB) September 11, 2018 -- Medical Device Software and Risk Management
**An FDAnews Webinar**
Sept. 19, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/mdsoftwareriskmgmt
Medical device risk management, specifically device software risk management, calls for a solid understanding of the documentation framework. This can be challenging because it includes elements from both the FDA view and the international standards view. It’s technical, but devicemakers must get it right.
So here’s expert assistance in plowing through the weeds.
Dan O’Leary, one of FDAnews’s most popular presenters, specializes in plain-English explanations of complex medical device issues. In this 90-minute presentation, he simplifies knotty areas of FDA and international compliance and sheds light on:
• FDA-CDRH guidance documents related to software
• Interrelationships among software development, pre-market submissions and post-market activities
• Determining the Level of Concern for a software device
• ISO 14971:2007: Understanding its role as the overarching risk management document
• IEC 62304:2006 & A1:2016 and its role as a software process standard
• The Software Safety Class of a medical device and how to determine it
• IEC/TR 80002-1:2009: How to use it
• And much more
Bonus Material: Participants receive an Excel workbook that helps determine a) the Level of Concern and required documentation and b) the Software Safety Class and associated process steps.
FDA’s QSR section on design validation has two interlocking requirements. One requires software validation and the other requires risk management. Interesting issues arise when both apply to the same medical device. And while ISO 13485:2016 doesn’t have an explicit reference to software in a medical device, the same issues apply there too.
It’s important for devicemakers involved in device design, cybersecurity and regulation to understand these issues.
Meet the Presenter:
Dan O’Leary is President of Ombu Enterprises LLC, a company offering training and execution in Operational Excellence focusing on analytic skills and a systems approach to operations management. Mr. O’Leary has 30+ years’ experience in quality, operations, and program management in regulated industries including medical devices and clinical labs. He is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Who Will Benefit:
Software development and risk management are best accomplished through a team. Team members who ought to consider attending include:
• Software managers and engineers
• Software quality specialists
• Risk managers
• Cybersecurity specialists
• Regulatory submission managers and specialists
Webinar Details:
Medical Device Software and Risk Management
**An FDAnews Webinar**
Sept. 19, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/mdsoftwareriskmgmt
Tuition:
$287 per site
Easy Ways to Register:
Online: http://www.fdanews.com/mdsoftwareriskmgmt
By phone: 888-838-5578 or 703-538-7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
Michelle Butler, FDAnews, http://www.fdanews.com, +1 703-538-7600, [email protected]
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