SOHInfo brings best-in-class literature and data capabilities to support your regulatory requirements: from 510k and PMA submissions to CER, ASUP, PMCF, CAPA, Black Label Removal or any other requirement. We begin with our Total literature review process which does not systematically exclude any potential or relevant sources.
Our meta-analytic staff is lead by Dr. Z.V. Tran, a pioneer in meta-analysis and publisher of the first meta-analytic publication in a scientific medical journal. Based on the methodology and process he has developed we produce the most complete and comprehensive analysis and reports to support your product requirements.
Support Regulatory Needs
Periodic Safety Update Report (PSUR)
Periodic Benefit Risk Evaluation Report (PBRER)
Post Market Clinical Follow-up (PMCF)
Corrective and Predictive Action (CAPA)
Continuous Data Updates
Continuously Scans all Selected Literature Repositories
Dynamically Identifies and Downloads
Continuously Maintains Data
Process Any Literature
Published Scientific Literature