Tools to Manage FMEA
In several industries, one of the most efficient ways to analyze reliability problems in the early stage of product development is through FMEA. Due to FMEA, manufacturers can act proactively toward reducing or removing potential failure.
One of the tools that the FDA endorses to help manufacturers deal will medication errors is FMEA. It is worth noting that prevention is always better than cure.
Acquire knowledge about technics and advanced tools
What You Will Learn
In this course, we will discuss the application of Risk Management to medical devices. This is a fascinating field and critical to ensuring safety.
Risk management for medical devices is an absolute requirement worldwide. Reviewing the Risk Management File is getting a critical and thorough assessment by regulatory bodies. Beyond that, good Risk Management just makes good business sense.
ISO 14971:2019 is the latest version of the most generally accepted medical device risk management standard. This program is tailored around that standard.
RISK FRAMWORK
To begin risk management activities for a product, a framework must be established to define risk values and acceptable levels. Learn about several approaches that are acceptable buy regulatory authorities.
TOOLBOX
FMEAs are commonly used to support risk management, but other tools can be helpful too. In this course, we'll discuss a few tools to identify ALL hazards/hazardous situations, so don't hesitate to use any tool in your toolbox.
RISK MANAGEMENT FILE
As per the standard, an organization must establish a "Risk File". Learn which essentially represents the compilation of all the artifacts produced and managed under the Risk Management process.
Example Curriculum
- Overview
- Scope
- Assignment of Responsibilities and Authorities - Part 1
- Assignment of Responsibilities and Authorities - Part 2
- Risk Management Activities
- Requirements for Review of Risk Management Activities
- Criteria of Risk Acceptability
- Method to Evaluate the Overall Residual Risk
- Verification Activities
- Activities Related to Collection and Review of Relevant Production and PostProduction Information
- Relationships to other Plans
- Integration
Receive Certification
At the end of this course you will receive a certification of training on the topics of ISO 14971 to be logged into your employee training record.
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