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From design, to engineering, to testing, and beyond, your medical device risk management process is an integral part for every phase of the project. Whether you are seeking to design a new product or improve an existing one, your medical device risk management process must be rigorous; especially if you are trying to gain FDA & CE approval.
If your medical device risk management process is not done correctly, this can lead to your project lacking certain mitigations. This not only affects your budget and increases time to market, but if found late in the process you may be required to redesign, redevelop, and retest your device throwing your project off the rails. Since having these mitigations and good practices are core to the FDA & CE approval process, you need a diligent medical device risk management process.
From design, to engineering, to testing, and beyond, your medical device risk management process is an integral part for every phase of the project. Whether you are seeking to design a new product or improve an existing one, your medical device risk management process must be rigorous; especially if you are trying to gain FDA & CE approval.
If your medical device risk management process is not done correctly, this can lead to your project lacking certain mitigations. This not only affects your budget and increases time to market, but if found late in the process you may be required to redesign, redevelop, and retest your device throwing your project off the rails. Since having these mitigations and good practices are core to the FDA & CE approval process, you need a diligent medical device risk management process.
Although it is important to have a diligent risk management process, if you spend too much time designing your process it can negatively affect your budget and timeline. It can be difficult to find the right balance. This is where Sterling’s expertise and experience since 1998 with over 1,400 projects can serve as an asset. Sterling has the proper certifications and can ensure that your device meets the proper requirements, so the FDA & CE approval process goes smoothly.
Our engineering methodologies are optimized to keep expenses low and design times down. We know how to minimize the total duration of the project and maximize your return on investment. This is possible due to our reverse engineering service which allows our clients to quickly create prototypes and utilize prior work to generate all the necessary documentation required for regulatory approval – all without compromising quality. We also employ agile project management by breaking down the project into incremental steps, and then thoroughly reviewing each step. This allows us to efficiently make changes and receive company feedback.
ISO 14971 is the application of risk management to medical device. It outlines the process you are going to follow for risk analysis. It entails going through risk analysis, a risk evaluation, risk mitigations, and a residual risk analysis and management. This standard helps guide the process for medical device manufacturers to ensure that the product is safe. Sterling’s experts can provide companies with support and documents needed for the ISO 14971 application.
As part of our human factors engineering process, we conduct a hazard analysis to identify potential hazards or hazardous issues from the environment and usability of the device. We also analyze residual risk of the device. Our goal is to ensure the device works properly and safely within its environment.
FMEA, which stands for Failure Modes and Effects Analysis, is a process which helps to identify issues before they happen. The first step in this process is to imagine possible risks with the software. The second phase involves deciding how detrimental the risks are to the software as a whole. Based on these steps, the third step is to develop safeguards or mitigations for those risks.
If your team needs support with creating a balanced risk management process, contact our team today.
February 16, 2023
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