How Apoplex achieved zero non-conformities mid-audit with Dovetail
- Cardiovascular diagnostics and stroke prevention
- AI-enabled software medical device
- Automated ECG analysis
- EU & US
- Class IIa & 510(k)
CASE STUDIES
Real regulatory work, real market outcomes.
Medtech teams use Dovetail to move from regulatory uncertainty to submission-ready evidence, certified products, and clearer launch paths across markets.
How Chromacare is building the next generation of at-home testing
- At-home biomarker monitoring
- Ferritin self-test
- Finger-prick test kit
- US & Health Canada
- 510(k) / Class III (Canada)
How STRIVE brings a high-stakes AI device for sepsis management to market with Dovetail
- Critical care / sepsis
- AI-enabled clinical decision-support software
- Software as a Medical Device
- EU MDR & US FDA
- Class IIB & 510(k)
How coobi got certified with Dovetail
- Substance-based addiction disorders
- Software
- Mobile App
- EU
- Class I
How Myoact got certified with Dovetail
- Physical therapy
- Software
- EU
- Class I
How LipoCheck got certified with Dovetail
- Lipodema, chronic care
- Software
- Mobile App
- EU
- Class I
