The concept of Risk Management for Medical Device and In-Vitro Diagnostic Device is complex because of the diversity of collaborators including medical practitioners, the organizations providing health care, governments, industry, patients and members of the public.
It is to be understood by the collaborators that use of such devices involve a great degree of risk even if the risk is reduced to an acceptable level.
ISO 14971 assist the manufacturers of the medical device to identify the hazards associated with the medical device.
Risk Management for Medical Device & In-vitro Diagnostic Device:
Risk Management for Medical Device is an integral part of the Medical Device Quality Management System (MD-QMS).
Risk Management for Medical Device includes establishment, implementation, documentation and maintenance of ongoing processes of Medical Device:
Risk Analysis: Identifying hazards and hazardous situations associated with a medical device;
Risk Evaluation: Estimating and evaluating the associated risks;
Risk Control: Controlling these risks, and
Production and Post Production: Monitoring the effectiveness of the risk control measures.
Medical Device & IVD Device Risk Management File:
For each type of medical device, the Medical device Risk Management file is maintained.
The elements of the Risk Management file include:
Reference of Design History File
Risk Policy
Risk Management Plan
Risk Management Report
Reference of PMS process,
Risk Management for Medical Device include Stages:
Risk Analysis
the Risk Analysis process
Intended use and reasonably foreseeable misuse
Identification of characteristics related to the safety
If during risk control option analysis, the manufacturer determines that risk reduction is not practicable, the manufacturer shall conduct a benefit-risk analysis of the residual risk. After the risk control measures are implemented, the manufacturer shall evaluate the residual risk using the criteria for risk acceptability defined in the risk management plan. If a residual risk is not judged acceptable using the criteria established in the risk management plan and further risk control is not practicable, the manufacturer may gather and review data and literature to determine if the benefits of the intended use outweigh this residual risk.
If the overall residual risk is judged acceptable, the manufacturer shall inform users of significant residual risks and shall include the necessary information in the accompanying documentation in order to disclose those residual risks.
Risk and Technical Documentation:
The residual risks are communicated to the intended user in the information supplied to manufacturer- Instructions for Use and Label.
Both risk management and clinical evaluation are interdependent. As a part of clinical evaluation, all the clinical risks are identified and are integrated in the risk management file.
Risk Management is also linked with PMS activities. The manufacturer will collect information from various sources about the similar medical devices and other products on market and shall consider the information as an input to risk management. Also, the conclusions of the risk and benefit-risk analysis will be fed into PMS report and Periodic safety Update Report.
Ways Consultants (WE) can serve Clients (YOU)
Uncovering the loopholes in the existing Documents
Analyzing and Identification of New Hazard’s that were previously unrecognized.
Drafting the protocol for Risk Management as per the current Harmonized Standard
Providing the clients with Medical Device Risk Management File
Conduct Risk-Benefit Analysis and demonstrate that medical device benefit outweighs the residual risk involved
Updating the risk management files with respect to post-market data updates.
We assist you to acquire your certifications within the given Time Frame
FAQ:
Software failure; exceptional misuse situations, such as sabotage or tampering with a medical device;
Novel hazards that are poorly understood, e.g. imprecise knowledge of the infectivity of the causative How to the agent of Bovine Spongiform Encephalopathy (BSE) prevents quantification of the risk of transmission;
Certain toxicological hazards, such as genotoxic carcinogens and sensitizing agents, where it might not be possible to determine a threshold of exposure below which toxic effects do not occur.
FMEA means Failure mode and effects analysis.
Identify various functions of the medical device.
Identify failure for each function.
For each failure identify the consequences (Potential effects)
Determine the severity of each effect. Mention the highest severity rating in the table for that particular failure.
Determine the root cause for each failure.
For each cause determine the probability of occurrence. Mention the occurrence of rating in the FMEA table.
Calculate risk priority number i.e. RPN= Severity X occurrence.
This will provide the potential failure in the order that is to be addressed.
Determine the actions to lower the severity or occurrence
The various methods of risk analysis are:
Fault Tree Analysis (FTA), Mind map Analysis, Preliminary Hazard Analysis (PHA), Failure Mode and Effects Analysis (FMEA), Parameter diagram (P-Diagram).
OR
Semi-quantitative, Quantitative, Qualitative.
Risk management in medical devices is a systematic process to identify, evaluate, control, and monitor risks associated with the use of medical devices and in vitro diagnostic devices. It ensures that any potential hazards or harmful situations related to a device are recognised and minimised to an acceptable level throughout the device’s entire lifecycle — from design and production to post-market use.
This process follows ISO 14971 and involves steps such as risk analysis, risk evaluation, risk control, and ongoing monitoring of residual risks. The goal is to protect patients, healthcare providers, and the public while also balancing the benefits of the device against any residual risks.
Medical devices carry various risks because they are used in healthcare settings where patient safety is critical. Risks can arise from hazards associated with the device’s design, materials, production, operation, or misuse. These risks include potential harm such as injury, infection, death, incorrect diagnosis, or device malfunction. Even when risk is reduced to an acceptable level through risk management, residual risks remain and must be carefully evaluated and communicated. Effective risk management, guided by standards like ISO 14971, helps identify, evaluate, and control these risks throughout the device’s lifecycle—from design to post-market use.
The ISO standard used for medical devices is ISO 14971. This standard provides a framework for the risk management process specific to medical devices and in vitro diagnostic devices, helping manufacturers identify hazards, evaluate and control risks, and ensure device safety throughout its lifecycle. The current version of the standard is ISO 14971:2019.
A risk management file for medical devices includes all documentation related to identifying, evaluating, and controlling risks associated with the device throughout its lifecycle. Key elements typically include:
1. Risk Policy
2. Risk Management Plan
3. Risk Management Report
This file documents risk analysis, risk evaluation, risk control measures, residual risk evaluation, benefit-risk analysis, and ongoing monitoring during production and post-production phases to ensure safety and compliance with standards like ISO 14971. Reference to the Design History File and Post-Market Surveillance (PMS) processes is also included.
Maven offers comprehensive support throughout the medical device risk management process, aligned with ISO 14971 and other regulatory requirements. Our experts help you by:
1. Identifying gaps in your existing risk management documentation
2. Identifying new hazards that may have been overlooked
3. Drafting or updating Risk Management Plans and protocols per the latest harmonised standards
4. Preparing a complete Medical Device Risk Management File tailored to your device
5. Conducting a thorough Risk-Benefit Analysis to demonstrate that the benefits of your device outweigh any residual risks
6. Integrating post-market surveillance data to update and maintain your risk management files effectively
7. Ensuring all risk information is properly documented and communicated in technical files and user instructions
