ISO 14971 Boot Camp is a unique program that achieves ISO 14971 compliance for your medical device within 30 days. After course completion, your staff will have all the tools to maintain ISO 14971 compliance — without the need for outside consultants.

An EZ Risk Manager consultant will come to your company (at a very reasonable rate) and help implement ISO 14971 for your medical device. This includes:

• Writing a Risk Management Operating Procedure tailored to your company’s specific needs
• Writing a Risk Management Plan for your medical device
• Conduct an initial ISO 14971 employee training session
• Organizing the Risk Management File
• Performing a Hazard Analysis
• Conducting a EZ Risk Manager training class
• Conducting risk assessment meetings to identify hazards, causes and risk controls
• Create the initial Device Hazard Analysis
• Write the initial Risk Management report
• Set up periodic risk management reviews
• Mentoring your staff

What’s the catch?

There are no catches or tricks. You have the following responsibilities if the boot camp is to succeed:

• You must purchase a copy of EZ Risk Manager
• Agree to hire an EZ Risk Manager consultant to work at your corporate site for up to 30 days
• Provide in-house resources. Your staff needs to help perform risk assessment and management. Boot Camp won’t work unless your people participate.