The Importance of Risk Management for Medical Devices

Risk management is an important part of the medical device product development lifecycle. It helps medical device manufacturers to ensure that the final product is reliable, works as expected and causes no harm. The main purpose of the risk management process is to reduce or mitigate the chances of failure in the product.

ISO 14971 Risk Management Techniques involve the identification, understanding, control and failure prevention of a medical device. Manufacturers should identify possible harms associated with the design of the medical device.

Steps Involved in Risk Management for Medical Devices

  • Risk Management Framework & Planning
  • Risk Analysis
  • Risk Evaluation
  • Risk Control
  • Reports and Documents
  • Production & Post-Production Information

Why should we perform Risk Management?

  • To identify hazards 
  • To estimate & evaluate the risk
  • Risk analysis is required by law
  • Identification of device design problems prior to distribution can eliminates extra costing associated with the medical device
  • To ensure safety of the medical device

Importance of Risk Management

The risk management process applies to the entire medical device life cycle from concept development to post-market activities. If the risk management process is not executed correctly in an organization, it will lead to the failure of the medical device. The failure of a medical device may result in device redesigning, remanufacturing, scrapping or reworking on an existing product or product recall. This increases the project timeline and budget. Hence, successful medical device developers and manufacturers emphasize the rigorous execution of risk management. Risk management is one of the essential and complex parts of the regulations, particularly if the medical device company wants to get an approval from the USFDA and CE.

IZiel’s Expertise

IZiel Healthcare has the expertise to write risk management procedures as per ISO 14971 and then create or restructure the risk management file as per the established procedures. IZiel Healthcare has broad experience creating risk management files from simple (Class I) to complex (Class III) medical devices. Our team uses the following tools to identify the risk associated with the medical device:

  1. Preliminary Hazard Analysis
  2. Failure Mode and Effect Analysis (Design and Process)
  3. Hazard Analysis
  4. Fault Tree Analysis

With the use of above defined tools, IZiel identifies, evaluates and controls the risk associated with a medical device to the patient, user and environment.

Risk Management Approach

IZiel Healthcare team uses the structural approach defined by ISO 14971 to construct the risk management file. The risk management file starts with drafting the risk management plan; it consists of the methodology of a risk management process and risk policy. Afterward, hazards, hazardous situations and harm are determined using tools like FMEA (pFMEA and dFMEA) and hazard analysis. The identified risks are then controlled or mitigated by applying risk control and the evaluation of residual risk then follows it. If the residual risk is not acceptable, then a risk versus benefit analysis is carried out.