May 21, 2013

Five Classifications for Risk Control Measures in Medical Device Development

Application Lifecycle Management
Security & Compliance

What Is Risk Control?

Risk control is a stage of risk management. In this stage, you take measures to mitigate risk and keep it under control. Thus, risk control.

Controlling risk is critical in many industries, particularly for medical device development. But it's often difficult to do.

That's why you need the right risk control measures.

5 Risk Control Measures

There are five risk control measures that organizations need to successfully mitigate risk.

Inherently Safe Design

You need to design a safe product — particularly if you're developing a medical device. And that means you need global design requirements or constraints that render the potential hazard or harm all but impossible.

Preventative Controls

Risk prevention is critical to mitigating risk. So, you'll need requirements and constraints that prevent a hazardous or harmful situation from materializing.

Corrective Actions

Not all risk can be prevented from the get-go. That's why you'll need "detect and correct" risk control measures. These will help you take corrective action when a hazardous situation is detected.

Mitigate

Risks need to be mitigated, especially if they are compromising the safety of your product. So, you'll need to make sure the severity of harm resulting from a hazard is reduced. It may not be eliminated entirely — and that's okay.

Soft Controls

There's always risk when you ship a product. After all, you can't completely control the behavior of your users. Including labeling, training, and operator instructions is a soft control for risk — and can help you reduce overall risk.

How to Simplify Risk Management

Risk control is just one area of risk management. After all, when it comes to managing risk, there's plenty to be worried about.

That's why it's time to make the whole risk management process easier. And traceability can help. 

Learn how to...

Simply Risk Management