The greatest challenge faced is an understanding of the intent of the written regulations and applying them correctly.
Understanding the GMP requirements of each component is critical to product and compliance success.
Timely compliance will ensure that your products will not be considered misbranded.
Designers and manufacturers of both devices and software must conduct due diligence and ensure regulatory compliance in protecting user data.
The agency’s latest announcements are indicative of its focus on risk reduction while promoting innovation.
When applicable, the process provides novel products with a speedier route to market.