The growth in the medical device usage has led to increase a complexity of making the medical device safe for human use. Risk management process need to establish by the medical device manufacturer to ensure device safety, usability & regulatory compliance.
Medical device manufacturer shall establish, implement, document and maintain an ongoing risk management process throughout the life of a medical device.
Risk management is a systematic approach of identifying the hazards, evaluating the risks, controlling the risk and monitoring all kinds of risks at all stages of the product realization starting from Raw material to post production activity as per the standard ISO 14971:2019. As such, ISO 14971 is acknowledged by FDA inside the 21 CFR part 820 QSR for medical devices. All the risk management activity and records are captured in the Risk Management File.
Risk Management is mandatory regulatory requirement worldwide. USFDA requires in the 21 CFR part 820, Europe requires in MDR 2017/745, likewise Canada, Australia, Japan and all other major markets require the application of Risk Management.
Risk Management process include the following elements:
- Risk Management Plan
- Risk Analysis
- Risk Evaluation
- Risk Control
- Evaluation of overall residual risk acceptability
- Risk Management review
- Production and post production information
Risk Management File provide a traceability between each identified hazard to the risk analysis, the risk evaluation, Implementation & verification of risk control measures, the results of the evaluation of residual risks.
Qualitative & Quantitative characteristics, characteristics related to loss of degradation of the clinical performance, List of questions in ISO/TR 24971 – Medical Devices – Guidance on the application of ISO 14971 is used for identifying the parameters which can affect the product safety. All these data should be recorded in the Risk Management File.
Medical device manufacturer needs to prepare following documents which covers the entire Risk Management requirements as per ISO 14971:2019.
- Risk Management Plan
- Preliminary Hazard Analysis
- Design Failure Mode Effect Analysis
- Process Failure Mode Effect Analysis
- Application Failure Mode Effect Analysis
- Risk Benefit Analysis
- Risk Management File & Report
Best way to structure the Risk Management file:
First of all, understand the Risk management terminology like potential failure mode, Hazardous situation, Hazards, Potential Harm, source of problem, risk control measures etc.
Consider the inputs from all the departments while carrying out the risk management practice like Sales & marketing, Design, QA, Production, purchase, stores, Regulatory & clinical etc.
Document the intended use, reasonably foreseeably misuse, identification of the characters related to safety, identification of hazards and hazardous situations that could affect the safety of the product, User & patient.
Decide the criteria for Risk acceptability based on the severity of the Harm and probability of the occurrence of the risk.
Gather the information or data for estimating the risks from sources of published standards, field data from similar medical devices which are already in use including publicly available reports of adverse events, usability tests employing users, clinical evidence, scientific or technical investigations, expert opinions etc.
The team can use one or more risk control options in the priority order
Inherent safety design & manufacture
Protective measures in the manufacturing process or in the medical device itself
Information for safety.
7.The team should collect and review the information relevant to the device in the production &post production phases.
8.The team should review the Risk management process prior to release of the device. The following checkpoints can be considered in the review process:
Is the Risk Management Plan Appropriately Implemented?
Appropriate methods used to collect information in the production & post production phases?
Is the Overall risk acceptable?
9.Consider Risk Management File as a live document and it should be accessible to the employees, stakeholders, outsourced vendors so that they can also update the Risk Management File and ensure that risks are mitigated to an acceptable range.
Assuming you have risk management file, then making it up-to-date can be very challenging as it will depend on Quality system you use. Our team keenly observe the facts and analyze the data, as medical device consultant we guide our clients to choose correct QMS system, apply ISO standard accordingly and create accurate and up to date files.
