Risk Management for Medical Devices 2016

Key Topics

• Integrating the new standard with ISO 13485 as part of your overall QMS
• Overview of the ISO14971 standard as it applies to medical device companies
• Modifying your design and development process to incorporate ISO14971
• Conducting a review of the intended use of your device
• Identifying hazards in your product or production process, and estimating their severity
• Stages of Risk Management as well as Tools and Techniques
• How to control those risks and monitor the effectiveness of the controls put in place
• Judging the probability that harm may occur from those hazards

Who should Attend

Attendees from:

• Technicians involved in new product development and manufacturing of medical devices
• Engineers
• Auditors
• Quality Managers
• Personnel involved in failure investigations and CAPA
• Regulatory Affairs personnel
• Design Engineers
• Validation professionals
• Project Managers involved in design and development