Risk Management for Medical Devices: An Overview of ISO 14971 & How To Apply a “Risk Based Approach” to Your QMS Processes

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 manufacturers a thorough insight into the specific risk-based changes they’ll need to understand to comply with the purposed standard.

18-year medical device industry veteran, QA/RA consultant, and founder of eQMS software platform, Jon Speer will be your presenter.

Watch the webinar

Specifically, you'll learn:
      • 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
Who should attend?
      • Quality Assurance and Quality Control
      • Regulatory Affairs and Compliance
      • Manufacturing
      • Supplier Management
      • Internal, External and Quality Auditors
      • Document Control
      • Production
      • Operations
      • Suppliers to the Medical Device Industry
      • R&D / Product Development

Hosted by

Moderator/Presenter: Jon Speer

Founder, Greenlight Guru


About Greenlight Guru

Greenlight Guru is the only quality management software platform designed specifically for medical device companies. The platform helps companies bring safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits and more. Greenlight Guru’s platform is used by thousands of users across the globe to push beyond baseline compliance and achieve True Quality for their medical devices.

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