CRO & Regulatory Support for Infection Prevention Devices

From concept to clearance, dicentra helps infection control innovations navigate regulatory and clinical pathways.

Supporting High-Risk Devices for Infection Control

We specialize in catheter lock solutions, antimicrobial coatings, biofilm disruption devices, and related technologies aimed at reducing catheter-associated bloodstream infections (CRBSIs) and hospital-acquired infections (HAIs).

Why Choose dicentra?

dicentra brings deep expertise in infection prevention devices, integrating regulatory, clinical, and quality support.
We streamline FDA, Health Canada, and EU submissions while aligning with hospital metrics and purchasing drivers to help you reach market faster.

Comprehensive CRO & Regulatory Services

dicentra provides end-to-end support including:

FDA 510(k), De Novo, or PMA pathway planning
Health Canada Medical Device Licence (MDL) applications
EU MDR support for Class IIa and IIb devices
Protocol development aligned with ISO 14155 and GCP
Site recruitment, trial startup, and patient enrollment
Clinical monitoring, SDV, and trial management

Quality, Safety, and Post-Market Support

Risk-benefit analysis and safety reporting
IFU development and labeling compliance
CERs and MDR Annex XIV documentation
Real-world evidence (RWE) studies
Hospital cost-savings and health economics modeling

Technologies We Support

Catheter lock solutions
Hemodialysis infection prevention tools
Antimicrobial coatings and embedded agents
Biofilm-targeting or disrupting technologies
Vascular access maintenance devices

Ready to Launch Your Infection Prevention Innovation?

dicentra helps navigate the regulatory, clinical, and market access journey for infection control devices.

Online Learning

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