Risk Management for Medical Devices:
An Overview of ISO 14971 & How To Apply a “Risk Based Approach” to Your QMS Processes to Address the Upcoming ISO 13485 Changes
LNS Research predicted risk would dominate more attention in mainstream quality management than all other topics in 2015, and it has.
The new ISO 13485 standard expects you to apply a “risk based approach” to all of your organization’s QMS processes, specifically stating you’ll need to apply risk management methods and techniques to every single QMS process, including outsourced processes as well.
This webinar will give product developers and manufactures a thorough insight into the specific risk-based changes they’ll need to understand to comply with the purposed standard.
16-year medical device industry veteran, QA/RA consultant, and founder of eQMS software platform greenlight.guru, Jon Speer covers:
• How to prepare for the coming ISO 13485 changes & ensure compliance
• An overview of the current risk management standard for medical devices: ISO 14971
• Relevance of ISO 14971 and the impending ISO 13485 revision
• How to incorporate risk management throughout the design control process and why it matters
• An overview of key risk management terms & definitions
• How to use risk management as a tool during design & development, and not simply as a “checkbox” activity
• How to apply a “risk based approach” to all your organizations QMS processes
Jon will also be answering all of your additional risk management, ISO 14971 and ISO 13485 questions live at the end of the webinar.
Who Should Attend:
• Quality Assurance and Quality Control
• Regulatory Affairs and Compliance
• Supplier Management
• Internal, External and Quality Auditors
• Document Control
• Suppliers to the Medical Device Industry
• R&D / Product Development
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