Manufacturing medical devices is complex, especially for companies quickly pivoting to manufacture a new device, or manufacturing a medical device for the first time.

Despite the need to move quickly, efficacy, safety and quality have never been more critical. In a highly regulated industry, all medical device manufacturers must maintain regulatory compliance.

Understanding leading practices around regulations, processes, data and collaboration can help you get up and running quickly, and with the best possible outcomes for patients and healthcare workers on the front lines.

Here’s guidance from Kalypso for the companies stepping up to help – whether you're a medical device company pivoting to manufacture a new-to-you device, or a non-medical device company manufacturing a device for the first time.