By David Jensen, Master Control
Design approval is more challenging with software-based medical devices because there is a higher risk of defects or functionality discrepancies occurring later in the production process. It’s critical that the delivered software code is capable of enabling the device to meet its intended use requirements.
So, how can you guarantee that your medical device will not only perform as designed, but also conform to the highest regulatory standards? First, it’s helpful to understand how regulators expect you to develop and implement design controls. Eventually, you need to transfer the product design to manufacturing while continuing to follow regulatory guidelines. In short, you must design for compliance.