A thorough and robust risk management process is essential for the development of a safe and effective medical device. Team Consulting employs an independent risk management lead in each of your projects. This helps facilitate a multi-disciplinary approach and allows you to focus on the risks, not the documentation.
Medical device regulations are constantly changing. Team has a dedicated risk manager so you don’t have to worry about staying up to date with industry best practice and regulatory requirements. Our risk manager makes sure we adopt a consistent approach across the company, working in compliance with ISO14971:2019.
Starting risk management early in the development of your product allows you to quickly identify and mitigate risks in your design, helping to avoid costly changes in the future.
At Team, we understand the importance of conducting an initial risk assessment on early concepts. Understanding risks can help inform your selection process and enable you to identify potential high-risk elements in your design that need to be addressed. These early risk assessments do not form part of the technical or design history file and can be conducted before creating a risk management plan, saving cost and speeding up time to market.
As we move through the development process, we:
There are variances in dFMECAs and in how they are implemented in different situations. For example:
A handheld drug delivery device which comprises up to 20 parts will require a different dFMECA approach compared to large medical devices comprising hundreds or thousands of parts.
There are also variances in dFMECAs across disciplines, such as mechanical, electronics and software. For example, you can predict the likelihood of a mechanical component breaking and use this to determine the overall risk, but when evaluating software we assume that all identified conditions will occur.
Team can help in various ways including standalone Risk Management (RM), gap analysis/expert review and risk management within a full medical device development. We have experience using many different tools in the risk management process:
