The medical device industry is enhancing the quality of life for people around the world. It’s also highly regulated by the U.S. Food and Drug Administration (FDA). From design to development planning to research and sales, the FDA closely monitors the work of medical equipment manufacturers.
This means it’s not enough to simply have an outstanding design. The FDA requires that medical equipment manufacturers thoroughly review their designs to ensure that they’re safe, effective and of the highest possible quality.
According to the FDA, design review is an intentional, deliberate and comprehensive examination of a medical device at various points in the manufacturing process. This ensures that the design meets the FDA’s high standards.
Here’s a look at the FDA’s design review requirements:
- All medical equipment manufacturers need to have formal, documented and regular review procedures in place.
- Reviews need to include a cross-functional team, including representatives from each group involved with the design, as well as at least one person who is not directly involved.
- All of the results of the design review need to be documented in the official design history file.
In general, the formal design review should:
- Assess the efficacy of early designs
- Identify any emerging problems
- Ensure that the project is making adequate progress
- Confirm that the project should move on to the next stage.
Because design review takes place frequently, each review will provide insight into the feasibility of the device. Early on, the reviews may focus specifically on the design. As the process moves forward, the focus of each review may shift outward, examining the efficacy of the proposed solution. By the end of the process, reviews turn to the viability of production. Is it possible to achieve large-scale manufacturing? Can mass production be achieved while ensuring that the integrity of the design remains?
Because research and development requires such a significant investment by medical device manufacturers, it’s important to have the right people involved in the process. This will ensure that the device is examined from every angle.
For more information about design guidance, contact Product Development Solutions today.