How to ensure compliance before your medical device trial begins

By Sandra Maddock, IMARC The only way to gain the FDA approval you need to bring your medical device to market is to ensure compliance at every stage in the clinical trial lifecycle. That starts long before you sign up your first subject. The planning stage is crucial because it sets expectations for how your team will work together to collect data, monitor results and protect your trial’s subjects. In this post, the first in a three-part series, we’ll cover five important steps you can take to ensure compliance before you start your medical device trial. Have a regulatory strategy A regulatory strategy aligns compliance activities with the business strategy, direction and structure your team needs to bring your medical device to market. Developing this strategy is a team effort that starts by identifying important questions about the product. For instance, is your device considered substantially equivalent to another device already on the market? If so, it may be eligible for the 510(k) FDA approval process, which may or may not require human testing. If it’s a new device unlike anything else on the market, it will need to undergo the full premarket approval process. You will also need to consider the type of medical device, its intended use and the implications. Establish study protocols Assuming your device requires a clinical trial, you need to establish protocols for moving forward with your trial. Proper protocol development is a balancing act. You want to ensur...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog IMARC Source Type: news