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 greenlight.guru, Jon Speer will be your presenter.

SPECIFICALLY you will 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

About greenlight guru

Greenlight Guru is the only Quality Management Software designed exclusively for medical device companies allowing them to bring safer devices to market faster while reducing risk and ensuring compliance.