Regarding shelf-life labeling for a new medical device, what is the best advice for the marketing department?

Performing accelerated aging studies for minimum periods is crucial for determining the shelf life of a new medical device. These studies involve exposing the device to elevated temperatures and humidity to simulate aging, allowing for the assessment of how the device will perform over time in real-world conditions. The goal is to establish a scientifically validated expiration date that ensures safety and efficacy throughout that time frame.

This approach provides essential data that regulatory bodies expect for the approval of medical devices, ensuring compliance with quality and safety standards. By establishing a validated shelf life, the marketing department can confidently label the device, ensuring that users understand how long they can maintain the device in storage before its performance may be compromised.

Conducting these studies reflects a proactive commitment to meeting regulatory requirements and consumer safety, which is fundamental for maintaining trust and credibility in the market.