Module 1: Design Requirements  

What are the requirements? What are you building/ designing and manufacturing? What is the purpose of your device? Here, we will look at how the Intended purpose will impact the entire design process and how we will use it to drive the requirements. 

Module 2: Design Inputs 

Here we will look at how the requirements will transpire into Design inputs for engineering the medical device. We will discuss how the inputs need verification and validation.

Module 3: Design Outputs

Here we will look at the outputs from the requirements and the design inputs, such as specifications, drawings and other important outputs which will then need verification and validation.

Module 4: Design Verification & Design Validation 

We will look at the needs to verify and validate your needs, inputs and outputs and what level of detail you need to go into depending on your device.

Module 5: Risk Management Overview: ISO 14971: 2019 & the Risk Management Plan

We will look at ISO 14971: 2019 what the requirements are and the risk management plan to outline risk activities.

Module 6: Risk Analysis

We will look at the process and different tools you can use and focus on risk analysis using the ISO 14971 standard. We will also look at some examples and how you can apply this, who needs to be involved and the importance of detail here. 

Module 7: Risk Management Report including Benefit-Risk Analysis 

We will look at Risk Management review, reporting and overall benefit-risk analysis against individual analysis and the requirements of the standard.

Module 8: Post Market Surveillance and ensuring the risk management file remains a living file. 

We will look at activities you need to document and monitor regularly to ensure the risk management file is not invalidated, updated and kept live.

Module 9: End-of-course assessment