Mdr-Mageddon: How To Survive Your Data Gaps With Cost-Saving Pre-Market &Amp; Pmcf Solutions
- How to identify critical clinical data gaps: processes and case studies
- How to develop clear safety and performance outcome measures and “thresholds” aka “acceptance criteria”
- How to build robust rationale that will convince Notified Bodies to keep your device on the market while you’re still collecting missing clinical data
- Understand your options: the pros, cons and costs of pre-market and PMCF activities
- Best strategies for choosing pre-market and PMCF activities for new devices, legacy devices, and devices with no data or literature
- Get the most bang for your buck! How to leverage PMCF activities for clinical data AND marketing claims gaps