You have dedicated years to develop and validate your product. However, use of your medical product in a controlled environment (clinical studies) versus actual use will likely not be the same. In addition, your product may not have been manufactured per your Device Master Record or MMR and has failed in the field.
If the failure caused or could have caused a serious injury, reporting product failure to the EU or US regulatory authorities may be required, and for the FDA you will need support with the MDR and 21CFR803. Our FDA expert consultants can help you.
Worst yet, you may need to recall the product. Regardless, all of your medical product's post market activity must now be monitored and considered.
Discover how customers use your product in actual practice. Gather and analyze post-market usage data and feedback. Conduct post-market clinical follow-up (PMCF) studies.