Medical and Diagnostic Device Development
Looking for an integrated medical device and in vitro diagnostic (IVD) CRO partner? When it comes to ensuring compliance and insight, keeping your trials and studies on track and bringing your medical device to market faster, developing a strategic partnership makes all the difference. From bench and preclinical testing to clinical trials and post-market device studies, we can help you to reach and maintain regulatory approval.
PMA or 510(k) submissions
countries with patient access
- IDE, PMA, HDE, BLA, 510(k), de Novo 510(k), CLIA Waiver
- MDR, IVDR, CDR, CE Mark & Design Dossier/Technical File
- Global strategic regulatory consulting, registries & submissions
- Regulatory report writing
Preclinical & Surgical
- Non-GLP & GLP (acute and chronic)
- Experimental surgery & model development
Imaging equipment and capabilities
Cadaver studies with physician/sales training
- Protocol development
- Feasibility/Pilot & Pivotal
- Global clinical trials development plan
- Diagnostic analysis
Site & patient recruitment/qualification
Centralized lab testing
- PMS & PMCF
- Real-world evidence studies
- Health economics
Work on your therapeutic compound solution at the same time as your IVD
Our integrated approach to both drug and device development, spanning all phases of the development lifecycle, can reduce your overhead and let you build both your therapeutic compound and in vitro companion diagnostic (IVD) at the same time.
- Biomarker identification & development
- Assay feasibility, proof of concept and validation
- Global clinical trial testing
Premarket approval application (PMA)
We have supported ~15 of the 19 FDA-approved companion diagnostics
Oncology & Immuno-oncology
Radiology (nuclear science)
Wound healing and traumatic injury
New: Philips Cath Lab – Allura Xper FD20
Fluoroscopy / OEC 9800 and OEC 9900
GE Visual IQ With 4D TEE & ICE
OCT Intravascular Imaging System
Endoscopic Towers (Olympus)
Laparoscopic Towers (Stryker)
Boston Scientific Galaxy
Audio / Video Conferencing Center
Conveniently located in the San Francisco Bay area, our AAALAC-accredited research facility is designed with experimental surgery and you in mind. This is a research space to accommodate both large and small groups, while giving you the feel of being in your own office.
One Expanded Device Solution, Designed Around You
By combining the core strengths of Covance and LabCorp with two key acquisitions of Chiltern and Preclinical Medevice Innovations (PMI), Covance has assembled an experienced device team ready to help you craft a device development path, uniquely Designed Around You. With these expanded solutions . . .
- You can use the same partner for your preclinical studies as your clinical trials.
- You can work on your therapeutic drug at the same time as your in vitro companion diagnostic device.
- You won't need a third partner to submit your regulations.
Receive a tailored device development experience, distinctly designed for you--tailored to your company, therapeutic indication and development strategy.