What Is Medical Device Risk Management

What Is Medical Device Risk Management
The Siliconreview
28 August, 2020

Risk mitigation is an important component of a medical device commercialization strategy. For this reason, medical technology developers partner with medical device consulting firms for technology’s strengths, weaknesses, opportunities and threats identification and analysis. The SWOT analysis is critical for informed decision-making. Medical device consulting firms encompass the following areas in medical device risk analysis:

  • Technology
  • Clinical
  • Competition
  • Target market acceptance
  • Regulatory
  • Financial

This analysis guides executive planning for resource prioritization in the formalized development process and commercialization plans.

Consulting firms use a systematic approach to identify, analyze, evaluate, and monitor risks in medical device development lifecycle. The results are maintained in a risk management file.

Role Of Consultant And Risk Management File

The risks analysis process begins when the device is in the design stage and continues with the medical device lifecycle. A medical device consulting firm helps a medical device company in the following ways.

  • Prepare risk management procedures as per the latest standards
  • Review the existing risk management file related documents. This review identifies and fills information gaps for risks, hazards and risk mitigation.
  • New risks identification
  • Risk management activities documentation. These activities include planning, reporting, assessments, risk control measures effectiveness and risk management file related post-market activities.
  • Risk-benefit analysis using the available literature and information provided by the manufacturer. The objective is to prove that benefits outweigh risks.
  • Conclusions and reports preparation

A medical device consulting firm stays up-to-date with the latest updates for risk management. It can also help the medical technology developer in getting the required certification.

Medical Device Risk Management Stages


  • Risk management framework establishment
  • Assigning responsibilities for activities in each risk management stage

Risk Analysis

  • Characteristics identification according to the intended purpose
  • Known and foreseeable hazards identification
  • Risk estimation for hazardous situations

Risk Evaluation

  • Risk probability and severity identification

Risk Control

  • Risk control measures identification for each hazard
  • Risk control measures implementation
  • Identification of new hazards after risk control measures implementation
  • Overall residual risk acceptability evaluation
  • Risk-benefits analysis for residual risks

Risk Management Report

  • Risk management report preparation.

Risk Management and Analysis Conduct

Risk analysis is a process in which the available information is used for risk identification and risk estimation during the medical device development lifecycle. Risk analysis is carried out in the following three areas:

  • Medical device intended use and safety-related characteristics identification; possible misuse and medical device quantitative and qualitative characteristics identification.
  • Medical device normal use hazards and faulty condition hazards
  • Risk estimation for each hazardous situation; harm probability and severity estimation

Risk Management Report Content 

The risk management report contains the entire risk management process’s review, including:

  • Whether the risk management plan is appropriately implemented or not
  • Overall residual risk acceptability
  • Whether risk control measures are appropriately taken or not
  • Whether the relevant production and post-production information is obtained using appropriate methods.
  • Conclusion

The risk management report documents the results of each step.

Every medical device developer desires to secure the highest possible return on investment. Risk analysis and management are critical to achieve the highest profitability. Therefore, a medical device company should work with a medical device consulting firm with decades of experience.