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Medical Device Risk Management Worksheet
ISO 13485 Risk Management Exercise
Analyze the risks associated with your operations
Risk management and risk analysis are required in ISO 13485 and is required to be applied throughout product realization. (Learn about ISO 13485 Risk Management)
Our risk management exercise will take you through the analysis of risks for the product realization steps required for your products. (You can also purchase the required Risk Management Procedure & Forms 13-EP-722 separately...see more info below)
How it works
The 18 page risk analysis exercise & PowerPoint starts with the preparation of process flow diagrams to describe the activities / steps. It continues with the use of an 8-column risk management worksheet that takes you through a series of information gathering actions designed to assist you in deciding whether or not a process step is at risk and taking appropriate corrective actions.
With the risk management package, you will:
This Product is an electronic document which you can immediately download upon completing your transaction.
 &  ISO 13485 Risk Management Exercise
Risk Management Procedure 13-EP-722 & Forms
Buy BOTH and save!
After placing BOTH items in your cart, use coupon code [13-Risk] for a $4 discount.
See complete list of ISO 13485 Procedures.
The risk analysis exercise is included as Task 15 in the ISO 13485 Workbook which guides the preparation, development, implementation and registration phases for ISO 13485 Medical Devices.
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