Published On: Wed, Sep 23rd, 2020

Medical Device Risk Management

Medical device companies work with consultants offering medical device market analysis services to identify the desired health care outcomes clinicians expect from a medical device. Clinicians use medical devices for diagnostic or treatment purposes. In addition to ensuring that the device meets the target market’s needs at a reduced cost, it is also critical to ensure that the device is safe for human use. For this reason, risk management is a critical part of the medical device development cycle. Risk management includes identification, understanding, control, and prevention of failures to ensure that the device safely and successfully delivers the desired results. Risk management is a structured tool to evaluate potential problems associated with the use of a medical device or drug. 

It is critical to identify and manage possible hazards in normal conditions and fault conditions. There are acceptability levels of risks. 

Risk Management

Risk management identifies, understands, controls and prevents failures that can be hazardous both in normal conditions and fault conditions. Risk management is important as:


  • It is a legal requirement.
  • It identifies medical device design problems prior to distribution.
  • It is a regulatory requirement.
  • It ensures medical device safety.
  • It ensures that unsafe devices are identified and corrected before they enter the market.


A well-written risk management program includes the following steps:


  • Defining responsibilities and accountabilities
  • Defining what requires authorization
  • Defining the required knowledge and skills
  • Documentation development and maintenance for procedures and policies conformance
  • Incorporating cross-checking and verification measures

Image/qimono via pixabay


Risk Control

In this process, a medical device development team reaches decisions and implements protective measures to reduce and maintain risks. Medical device risk control and monitoring activities include actions for elimination or reduction of each risk. The process may incorporate multiple risk control measures. Risk controls begin with design input. There is a fixed risk controls hierarchy that includes:



  • Design’s inherent safety
  • Device’s protective measures
  • Warnings, maintenance schedules and other safety information 


The manufacturer monitors risk throughout the lifecycle. 

Risk Control Measures 

These measures include: 


  • Protective measures 
  • Safety information


Safety Risk Zone 

This zone identifies each hazard’s residual safety risk to determine its acceptability. Acceptable hazards fall into Safety Risk Zone 1. Conditionally acceptable hazards are Safety Risk Zone 2. However, these hazards require analysis and mitigation. Unacceptable hazards are Safety Risk Zone 3.

Risk Mitigation 

Risk mitigation includes three lines of defense. The first line of defense attempts to avoid or eliminate causes of failure. The second line of defense identifies or detects the failure earlier. The third line of defense reduces the consequences/impacts of failure. Risk mitigation identifies effectively implemented risk measure controls to reduce hazard’s likelihood or minimize hazard’s severity. 

Hazard Analysis 

The medical device team conducts preliminary hazard analysis before developing the final design. This establishes baseline hazards associated with the medical device. This analysis lists the device’s operating requirements and major components. This also includes potential hazards evaluation. Following are the common hazards to be evaluated:


  • Reactivity 
  • Flammability 
  • Toxicity 
  • Sensitivity to temperature, humidity and other environmental factors 
  • Electronic or mechanic hazards
  • Human factors   


Risk management is critical to medical device development. Medical device consulting firms help medical device companies in the analysis of the following types of risks:   


  • Technology risks 
  • Clinical risks 
  • Market acceptance risks 
  • Competition risks 
  • Regulatory risks 
  • Financial risks


Author: Daisy Bell

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  1. […] time the FDA approves a new medication or device, they have to weigh the potential risks against the benefits. With devices, that often means fast tracking items that are essentially […]

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