Of iso 14971

Before ISO , no other safety standards addressed the risk management of medical devices. This is both a blessing and a curse. Overall, this standard defines a set of requirements for managing the risks of medical devices. For instance, manufacturers must:. The above-stated requirements apply to all phases of the life cycle of a medical device, from the initial conception to the final decommissioning and disposal.

This standard applies to all types of medical devices, including software as a medical device and in-vitro diagnostic medical devices. A medical device is any apparatus, instrument, appliance, machine, implant, material, software or another article that is intended by the producer to be used for human beings for one or several of the following medical purposes:. In addition, the primary intended purpose cannot be achieved by immunological, metabolic or pharmacological means, but it may be assisted by such means.

Close of voting. Proof returned by secretariat. International Standard under systematic review. This may also interest you. Once again, understanding the intended use and the steps involved in using your medical device should help guide you through this process.

The foreseeable sequence of events that someone will go through in using your product, which can result in a hazardous situation, should also be identified. As you can see from the provided example, in order for the Hazardous Situation to occur, there are a series of things that must happen first Foreseeable Sequence of Events.

Hazards and Hazardous Situations are much broader than just failure modes. I should also remind you of the definition of harm. Harm is physical injury or damage to the health of people, or damage to property or the environment.

A common technique that is used is defining descriptions for various levels for both severity and probability of occurrence. Often times, probability of occurrence might include quantitative terms such as the example above.

Note that there is no medical device industry standard for severity and probability of occurrence. When estimating severity and occurrence for Harms of each Hazardous Situations, you should leverage objective evidence to support your estimates. Objective evidence can include things such as:. For each Hazardous Situation, you need to estimate the Severity and estimate the Occurrence in order to ultimately estimate Risk.

A common technique for this is to establish a Risk Acceptability Matrix which I will expand on further under Risk Evaluation. The table below shows the occurrence and severity levels. Once Risks for each Harm has been estimated, you now need to evaluate these risks to determine if risk reduction is required. In the section above, I provided a sample of a Risk Acceptability Matrix.

A common practice for Risk Evaluation is to identify which risk zones are acceptable and which require risk reduction. For those selling in the US, the typical practice is to correlate the low zone with an acceptable risk and the high zone with unacceptable risk.

During Risk Evaluation, you identified items that require risk reduction. Risk Controls are about reducing identified risks to acceptable levels. Risk Controls are measures that you take with your medical device to reduce the risk.

While it is possible to reduce the severity of an identified harm, generally speaking, a Risk Control will have the most significant impact on the probability of occurrence of a harm.

All too often, when Risk Controls are identified, they are more likely to involve adding additional information to a label or instructions for use. But please remember this. You should consider Risk Control options according to the following priority:. Risk Controls should be focused on the specific design features first and labeling as a last resort. And yes, it is possible to include multiple Risk Controls to reduce risk. This is actually a best practice.

Risk Controls is an area with very strong ties to Design Controls. And if you follow my tip above about using Design Outputs, Design Verifications, and Design Validations as Risk Control measures, then implementation is a bit easier since these items are required as part of your Design Controls process. Once Risk Controls are implemented, then you need to verify that this has happened and determine the effectiveness of the measures taken.

Record of this shall be documented. Now that Risk Controls have been implemented and verified for effectiveness, it is now time to re-evaluate the risks.

You are going to use the same criteria you established for severity, occurrence, risk levels, and risk acceptability as discussed before.

The objective is to evaluate the residual risks to determine if the risk level has been reduced to acceptable levels or if following EU MDR, is reduced as far as possible.

In the event the residual risks are still unacceptable, revisit Risk Controls to identify other means to reduce. The concept of a benefit-risk analysis is this: the medical benefits of the medical device outweigh the residual risk. After you identify Risk Controls and evaluate residual risks, it is still possible that you will have some risks that are still in the unacceptable level.

In these cases, it might make sense to conduct and document a benefit-risk analysis BRA. The BRA must be documented and provided objective evidence and rationale for why the medical benefits outweigh the unacceptable risks.

If you are able to do so, the BRA is a special provision for moving forward with unacceptable risks. An important thing to remember is financial reasoning should never be included in a BRA. Please note that the benefit-risk analysis topic can be a slippery slope. You should definitely take every possible measure to reduce the risk first via Risk Controls. The rationale is the regulations state that all risks shall be reduced as far as possible.

This is something to consider when you are drafting your risk management plan. There is another twist to consider after you have implemented Risk Controls. If so, then you need to add the hazards and hazardous situations and go through the risk management process steps identified throughout this guide. The next step is to now evaluate the overall residual risk acceptability of the medical device on its whole entirety. To do so, you are going to use the same severity, occurrence, risk level, and risk acceptability criteria you use throughout the process.

If you determine that the overall residual risk of the entire product is not acceptable, this is another case where you can conduct a benefit-risk analysis. If you determine that the overall residual risk of the entire product is acceptable, document this decision and support your rationale.

I recommend including this in your Risk Management Report. Before going to market with your medical device, the results of all steps in your risk management process shall be reviewed to ensure completeness. You need to establish a Risk Management Report which will summarize all your risk management activities and include any benefit-risk analyses and explanation of overall risk acceptability. The Risk Management Report should also discuss your plans for evaluating risks in production and post-production.

I recommend that you have executive management in your company approve the Risk Management Report. Unfortunately, risk management efforts have a tendency to trail off and be forgotten once a product is launched. You need to ensure that post-production processes that you have in place to support your QMS are feeding into your Risk Management process. Complaints need to tie into Risk Management. Did the complaint identify a new hazard or hazardous situation not captured?

Does the occurrence of harm align with what you estimated? Customer feedback needs to tie into Risk Management.

Did you learn something about your product that impacts the Risk Management? The point is this: Once you begin manufacturing and launch your medical device into the market, you are going to learn a great deal about the product. You need to make sure that your Risk Management documentation is current and as best as possible, an accurate reflection of the actual risks your product poses. I do not recommend taking this angle.

Yes, these forms should identify whether or not risk management is impacted and require an explanation if not. If risk is impacted by one of these post-production events, do yourself a HUGE favor and make an update to the actual Risk Management File that you worked so hard on during product development. To help you with Design Controls and Risk Management. To help you align with regulations. As easily as possible.

Designed specifically and only for medical devices. There is no reason that you have to take that kind of risk today. We've built Greenlight Guru especially to solve the unique challenges medical device companies face with Design Controls and Risk Management. Looking for a risk management solution that aligns with the latest version of the ISO standard that will help you bring safer medical devices to market faster with less risk?

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Life cycle Previously Withdrawn. Final text received or FDIS registered for formal approval. Proof sent to secretariat or FDIS ballot initiated: 8 weeks.