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Are you confident you have designed a safe and effective product?
Ensuring your product is safe and effective is the key goal of risk management within medical device development. But at CDP we think about risk in broader terms, that the device shouldn’t just be safe and effective, it should be help in a meaningful way. We use risk management principles from the earliest stage possible within the development process to ensure that the optimum outcome is delivered for all the user groups who interact with the product.
For medical devices and combination products, we work to ISO14971 standards for risk management and have developed many products using this structured way of working. However, we also have experience with risk management outside of medical products, both to meet regulatory requirements, such as those in the machinery directive and as a tool to develop successful products through ensuring all possible failure modes are considered and mitigated.
If you have concerns about your product or perhaps a design, you have bought from a 3rd party? We can also work with your team to assess the potential risks and create suitable mitigation plans to reduce them.
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