Labeling

Investigational Device Exemption

Investigational Device Exemption

An investigational device exemption (IDE) allows for investigational devices to be used in clinical studies to collect the proper safety and effectiveness data….

Label Changes and the 510k

Label Changes and the 510k

Submitting a 510k for a medical device can be a long and confusing process. When a 510k is submitted the device itself...

Regulation and Labeling

Regulation and Labeling

Complying with all regulatory requirements for a regulated product is a massive challenge. Meeting all labeling...

Understanding Label Claims

Understanding Label Claims

‌  Claims are defined statements, symbols, or wording that are made on a product. They can be advertising,...

Ready to learn more about working with us?

Pin It on Pinterest