United States
Medical devices are highly regulated in the United States. Since U.S. regulatory compliance for MedTech is stringent and continuously changing, staying up-to-date on the latest standards helps businesses avoid costly violations and improve the efficacy and safety of...
FDA
The new article describes the matters related to periodic evaluations the authority intends to conduct to ensure compliance with the applicable regulatory regiments.
FDA
The article describes the approach to be followed when submitting information related to sterilizing medical devices intended to be marketed and used in the US.
FDA
The new article describes in detail the approach to be applied concerning documenting the review process, its completion, and reporting.
