To satisfy medical device reporting requirements and pass an FDA inspection with flying colors, manufacturers need to do their homework, an operations management expert says.
They should ensure that their quality management system protocols are well-documented and cover all regulatory requirements, and that they’re following an audit program to ensure compliance with their own procedures.
In FDA device warning letters, complaints are one of the most commonly cited sections in the quality system regulation, said Ombu Enterprises President Dan O’Leary during a recent FDANews webinar.
“Every MDR has an associated complaint with it. So, what that means is that in order to understand how to properly implement MDRs, we've got to understand how to properly implement complaints,” O’Leary said. Based on his own research, about one-third of all device warning letters have MDR citations — with 40 percent including citations for complaint handling. — Jennifer Lubell