Our Blog

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

Slider
Implant Cards: Further MDCG Guidance
The Medical Device Coordination Group (MDCG), the advisory body of the European Commission composed of representatives of all member states, issued a guidance document dedicated to the Implant Card (IC) to advise the...
FDA Guidance on Third Party Review Program
The Food and Drug Administration, the US authority responsible for medical device regulation, issued guidance dedicated to the Third Party (3P510k) Review Program allowing recognized third parties to perform the review...
FDA Guidance on Electrosurgical Devices
The US Food and Drug Administration (FDA), the authority responsible for medical devices regulation, issued guidance dedicated to 510(k) premarket notification submissions for Electrosurgical devices for general...
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...