Our Blog

Never miss a thing! The latest regulatory news and updates are always on our feed.

Slider
Document Submissions in Mexico: Guidelines
All information submitted to the Mexican medical device regulating authority should be provided in the particular form set forth in the appropriate submissions guidance. The authority provides an exhaustive list of...
Bone Anchor Devices: FDA Guidance
The Food and Drug Administration, the US authority responsible for medical device regulation, issued guidance dedicated to premarket notification 510(k) submissions for bone anchor devices. Bone Anchor: General...
Overview: FDA NESTcc Methods Framework
The National Evaluation System for Health Technology Coordinating Center (NESTcc), an organization created and supported by the US Food and Drug Administration (FDA) that focuses on the development of new approaches to...
FDA NESTcc Data Quality Framework
The National Evaluation System for Health Technology Coordinating Center (NESTcc) is an organization created by the US Food and Drug Administration (FDA) in collaboration with the Medical Device Innovation Consortium...