What phase follows regulatory approval in the medical device life cycle?

The phase that follows regulatory approval in the medical device life cycle is market launch. Once a medical device has obtained the necessary regulatory approvals, it is ready to be introduced to the market. This transition from approval to market launch involves several critical activities, including ramping up manufacturing capabilities, establishing distribution channels, and implementing marketing strategies.

During the market launch phase, companies must also ensure that the product is available to healthcare providers and patients, and they typically focus on educating users about the device's features, benefits, and proper usage. This phase is crucial because it can significantly impact the product's success in the marketplace, including market penetration and sales performance.

The subsequent phase, post-market surveillance, occurs after the market launch. This involves ongoing monitoring of the device's performance in the real world to ensure its continued safety and effectiveness, as well as to collect feedback and data that may influence future regulatory submissions or product improvements. However, it is important to recognize that post-market surveillance cannot happen until the device is actually on the market, which is why market launch is the appropriate phase that immediately follows regulatory approval.