Quality

FDA Launches Device Software Pre-certification Pilot

The FDA’s new pilot program for pre-certifying software for digital medical devices is up and running and companies can now apply to take part in the program. The goal of the new approach is to determine whether a company meets the necessary quality standard. Read More

What Device Manufacturers Can Learn From FDA’s Inspection Data

Medical device quality managers that don’t want to wind up a statistic in a future FDA report on quality deviations should dig deeply into the agency’s recently released report on inspections, Form 483s and warning letters, says Michael Gaba, a partner in the law firm Polsinelli. Read More