digital health

medical device FDA’s New Digital Health Report

To update health care providers, patients, and developers about some of the risks and benefits surrounding software products, the FDA released a report based on impact to patient safety, health benefits and risks, and best practices.

Pamela Rentz's picture
Pamela Rentz
doctor using tablet FDA Pilots Program to Pre-Certify Digital Health Software

As healthcare undergoes a digital transformation, how can the traditional regulatory process keep pace? The FDA recently announced the initial participants in a pilot program that will pre-certify digital health tech companies that meet quality standards for software design, validation, and maintenance.

Pamela Rentz's picture
Pamela Rentz