Systematic Literature Reviews (SLRs) are a critical component of regulatory compliance for
Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF), and Risk Management
documentation under EU MDR and IVDR. However,
traditional SLR methods are time-consuming, resource-intensive, and prone to inconsistencies.
Celegence simplifies the SLR process with AI-powered automation,
cutting review time by up to 60% while ensuring data integrity and compliance. Our expertise
in regulatory-compliant SLR methodologies ensures that manufacturers
efficiently gather, analyze, and interpret clinical data to support regulatory submissions.
Time Reduction Case Study
EUMDR Checklist
Medical Device Brochure