QFI offers a wide-range of market surveillance and product complaint handling services. For manufacturers and other medical device economic operators seeking supplementary professional technical support to assist processing and investigating complaints, produce reports or specific topical assistance, we can quickly, efficiently and seamlessly augment complaint and field action resources. Our technical specialists possess direct, hands-on practical experience of dealing with product complaints, having prior roles at Competent authorities or other regulatory agencies also at leading medical device manufacturers.
We also help in cases of unrealistic/ zealous product complaint process remediation, where we can eliminate unnecessary work manufacturers are frequently mal-advised to embark on, devise efficient procedures fulfilling global medical regulations and applicable standards.
QFI can analyse:
- complaints properly
- produce market surveillance and periodic reports
- ensure proper feedback to risk management and remediation initiatives
- ensuring otherwise un-contained CAPA fixes are not mistakenly applied instead of achievable/ practicable compliant solutions