Medical Device CRO
AstraOne is a full-service medical device CRO delivering pivotal, pre-market, and post-market studies for Class II and Class III devices, including connected and software-enabled devices.
What we deliver
Pivotal device clinical trials
IDE, 510(k), De Novo, and PMA-supporting clinical studies with adaptive and traditional designs.
Usability and human factors
IEC 62366-aligned usability studies with formative and summative evaluations.
Post-market clinical follow-up (PMCF)
PMCF studies and surveys supporting MDR compliance and label expansion.
Clinical evaluation reports
CERs, literature reviews, and clinical strategy for MDR, FDA, and international submissions.
Real-world evidence studies
Registry, RWE, and observational designs supporting reimbursement and label evolution.
Connected and wearable devices
Device plus software combination studies with integrated data pipeline validation.
Built for regulatory-grade evidence
- IDE, 510(k), De Novo, PMA, and MDR-ready evidence
- Integrated clinical, biostatistics, and regulatory teams
- Global site network for enrollment and follow-up
- Device logistics, accountability, and reverse logistics
Frequently asked questions
What does a medical device CRO do?
A medical device CRO runs the pre-market and post-market clinical studies needed to support FDA and international submissions — including pivotal trials, usability studies, clinical evaluation reports, and post-market clinical follow-up.
Ready to scope your study?
Talk to our clinical operations team about protocol design, recruitment, and execution.