Page 246 - Safety Risk Management for Medical Devices

Risk Management and Product Development Process 225

After the approval of the project and commitment of resources, design and devel-
opment begins in earnest. As designs of the product, the process, and the user inter-
faces become available, FMEAs begin. The FMEAs provide feedback to the design
team to improve the design. Another benefit that the risk management process offers
to the product development team is the estimation of risk, which not only enables the
teams to make risk-based sample size determination for verification testing, but also
alerts the design team to potential problem areas. The sooner the design team knows
about the problem areas, the less costly it is to fix them.
After risk assessment is completed, benefit risk analyses are performed to provide
evidence that the benefits of the device outweigh its risks. This is a critical part of the
regulatory submission, without which you cannot get approval for commercialization
of your product.
After the release of the product, risk management continues to monitor the prod-
uct in the production and postproduction phases. New knowledge gained about the
product performance is fed back to the risk management process, and evaluated for
potential updates and/or improvements to the prelaunch risk estimates.