A Smooth Route to the New Medical Device Regulation
The new MDR introduces several changes that manufacturers must consider right away.
Tag Archives: MDR
MDRs: Establish a Procedure
Define, document and implement!
Eight Things You Need to Know about Unique Device Identification
Are you UDI-ready? Get the facts to achieve compliance fast.
eMDRs Part Deux: FDA on a Mission
The agency is focused on ensuring device establishments accelerate compliance with the eMDR process.
The Integration of Complaint Handling and Risk Management
A review of the important aspects of risk management and post-market surveillance processes, and how to resolve common concerns.
Endoscopes, Too Little and Too Late
If complex medical devices such as endoscopes and duodenoscopes cannot be reprocessed safely, why is this practice permitted?
No Established Procedure for Servicing will Result in a Form 483 Observation!
If your establishment is entering equipment into commerce that is deemed a finished medical device and product servicing is expected during the normal product life-cycle, then compliance with §820.200 is mandated by the QSR. Mandatory means “not optional” in the eyes of the regulatory gods at FDA.
