MDR Procedures, Software Validations Net German Firm 483
FDA investigators found sloppy medical device reporting procedures and a lack of software validation during an inspection of Rapid Biomedical’s manufacturing plant in Bayern, Germany.
The facility’s MDR procedures didn’t include a system for timely identification, communication and evaluation of events that may be subject to MDR requirements, the agency said in a Form 483 report.
In addition, software used in the firm’s production and quality system was not validated and documented. The facility had used the software since 2005 for manufacturing, creating device history records, traceability and other quality management activities.