It doesn’t matter how sexy, high tech or innovative your medical device is.
You must, and regulatory authorities demand this, understand and mitigate risks for the user if you want to get approval to sell your product.
If you had a sense of what you needed to do, to take care of this, what would you then do?
After watching this video, you may want to think about how you’ll put what you learn into action.
In this bite-size video, we’ll continue our exploration of the map of medical device development.
We’re taking a look at the Risk Management track, it’s an overview of the steps you’ll need to take to identify, understand and mitigate risks in the manufacture, assembly, distribution, use and disposal of your device.
In the time available to us, we can’t go into great detail, so please get in touch to find out more about any aspect of this topic.
There’s a straightforward way to do this, which benefits your device throughout development and beyond.
As you might expect, there’s a standard (ISO 14971) that describes the steps for Risk Management, steps that include:
First off, you’ll need to define your approach to Managing Risk, throughout the life cycle of your medical device. In our experience, good Risk Plans are updated throughout the life cycle, they’re not left in a cupboard to gather dust.
To objectively assess each potential risk, it’s helpful to pull together a list of the Hazards and Harms for use of your device. Risk is the combination of the probability of a harm happening and its severity
Design Review – Confirm you’re on the right track and make sound project decisions based on concrete data. Search for our video “4 w’s of Design Review” to learn more about these.
Risk Analysis – has two parts;
- Firstly identifying potential risks for the design, manufacture, assembly, distribution, use and disposal of the product.
- The second part is evaluating each of these against the Hazards and Harms I mentioned just now. You’ll prioritise these risks based on their probability and the severity of the harm that could result. This allows you to focus on addressing the most important ones first.
Risk Mitigation – now that you understand the risks, you’ll need to develop ways to mitigate them as far as possible. Far too often, people jump straight to putting a warning or legal wording in the user manual.
This isn’t good enough!
Regulators in the US and EU expect you to look at design changes first, then protective measures such as alarms, limits. Only if neither of these can be done, should information in a manual be considered.
These mitigations must be tested, to see if they work and whether they introduce new risks or Use Errors into the device design. The results should feed back into design controls and Human Factors evaluation.
Mitigation Verification – once it looks like the mitigations are effective, you’ll want to generate test data that verifies their effectiveness. This it usually done as part of Design Verification and Design Validation stops on other tracks.
Residual Risk Assessment – having hopefully verified that mitigations do work, update your risk analysis to reflect it. You’ll need to consider whether the residual risk (what’s left after all the mitigations) is acceptable against criteria you’ve put in your Risk Plan.
This step can flag up the need to put in place more mitigations, and that’s ok.
The final step in development is to document what you’ve done in a Risk Management Report that also concludes on the safety of your medical device.
Of course, it doesn’t stop there. You must undertake Post-Market Surveillance when your product is on the market.
You’re expected to keep tabs on similar devices, not just your own. Regular review of the risk management file for your product is expected, as well as taking action when this information changes existing risk estimations.
As you watched this video, you’ll have started to think about how you can go about addressing each of these stops properly, making the best of each step of your journey. You may now want to get some guidance to turn your thoughts into concrete actions.
Perhaps you’re thinking of increasing your knowledge of Risk Management. Clients tell us they love our bespoke Risk Management training, with its practical approach to the subject.
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