White Paper: Common Technical Documentation Deficiencies Cited by Notified Bodies
We have supported many MDR implementations and want to share what we have learned about what notified bodies expect in terms of quality and detail. The biggest lesson: Expectations are a lot higher than manufacturers were used to under MDD. Submitting documentation that has technical gaps will result in notified body findings. The best approach is to be as thorough as possible.
With a limited number of rounds of questions and tight deadlines for corrections, manufacturers would be wise to take every possible step to eliminate gaps before the first submission. This white paper captures the most common deficiencies found in technical documentation and provides real-world examples so you can avoid making the same mistakes that lead to extensive (and costly) remediation.
This white paper covers the most common MDR deficiencies in:
- Technical documentation
- Labeling
- Clinical evaluation
- Post-market surveillance
- State of the art
Our list of actual notified body findings are presented in plain language, so you can easily cross-reference your draft submissions to check for avoidable mistakes.
Fill out the form to get access to your copy today.
.svg "white RQM logo")