Risk management is just plain hard — complicated, conflicted, confusing. And it’s getting harder.
ISO 14971 is being revised. The new standard adds new definitions… changes the clause numbering… introduces new requirements… changes many of the annexes and moves them to a new document.
And at the same time the EU is in transition to new regulations. There are new concepts… new risk reduction requirements… and new applications. Two areas of impact are side effects (residual risk) and benefit-risk analysis as a life-cycle requirement.
Are you prepared for these changes? Have you worked on risk analysis and evaluation with your team? Are your risk management files and plans up-to-date?
This Medical Device Risk Management virtual workshop on Dec. 10th 2020 will cover everything you need to implement an efficient and effective risk management system. Through expert advice, you’ll gain a basic understanding of medical device regulations, discover how ISO 14971:2019 will impact your procedures and work to identify gaps in your implementation plans.
Your risk management guide, Jeff Kasoff, will share tips on how to define acceptable risk, create a risk management plan, and complete an overall residual risk evaluation. He’ll also share how these requirements connect to the EU-MDR and what organizations need to do to match the two standards.
Virtual conference takeaways:
· Basic medical device regulations and standards
· Risk management files and plans
· Acceptable risk definitions and the risk matrix
· Risk analysis, evaluation and control
· Residual risk evaluation
· Risk management review
· Production and post-production requirements
· EU-MDR adjustments and expectations
· ISO 14971:2019 implementation and process standards
· Annex I risk-specific requirements
Implementing ISO-14971:2019 will require a careful look at your current risk management systems and a deep understanding of where they need to go. Let us help make that process simpler and more successful.
Join us for this virtual workshop by registering today.
Duration: 8 Hours
Group of 3 to 5 +1 Thumb Drive or 5 online Recorded version
Group of 6 to 10 +1 Thumb Drive or 10 online Recorded version
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For the previous 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similarly responsible for quality system oversight. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.