The Healthcare Supply Chain Association releases a laundry list of areas in which device companies and providers must increase security of devices and networks.
The agency wants to make sure that all patients receive information about the risks of the female contraception device prior to implantation.
Managing suppliers is critical, and your processes in doing so must be documented.
Next month cybersecurity experts from FDA, medical device companies and other healthcare organizations with gather to talk strategy and best practices for designing and evaluating secure technologies.
APRIL FOOL’S! FDA inspectors don’t want to discover hungry rodents enjoying a meal of device history records.
About the size of a quarter, the patch transmits real-time glucose readings every five minutes.
The issue causes interference in the accuracy of the test method.
Excessive focus on compliance can create hurdles in cultivating quality and innovation.
Although an expensive and challenging regulatory market, Japan’s aging population offers plenty of opportunities for device companies.
Manufacturers must re-evaluate existing regulatory and compliance strategies to meet the new requirements.