Device manufacturers need to keep their risk documentation up to date throughout the total product life cycle by monitoring production and post-production information, according to LCDR Thomas Peter, an investigator and medical device specialist at the US Food and Drug Administration (FDA).
“We need to establish that risk management doesn’t end when you initially design and develop your device and transfer it to production. Unfortunately, that’s what we have seen, more often than we would like,” Peter told attendees at the 2023 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative and FDA.
Peter, who is a Division 1 Investigator/Medical Device Specialist in the Office of Medical Device and Radiological Health Operations in the FDA Office of Regulatory Affairs, discussed the use of production and post-production information in risk management, as well as some risk-management related deficiencies seen during inspections…
