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.
| SLR Protocol Development | Structured methodology for data collection, analysis, and synthesis to ensure compliance with MDR and IVDR requirements. |
| AI-Powered Literature Searches | Automated searches across PubMed, Google Scholar, FDA MAUDE, and other regulatory databases, improving accuracy and retrieval rates. |
| Data Extraction & Appraisal | AI-driven screening, categorization, and quality assessment of clinical studies and publications. |
| State-of-the-Art (SOTA) Review | Up-to-date benchmarking of industry standards, device performance, and safety data. |
| Risk-Benefit Analysis & Gaps Assessment | Identification of missing clinical data and potential compliance risks. |
| Regulatory Document Integration | Seamless SLR integration with CERs, PSURs, PMCF Plans & Reports for consistency. |
CAPTIS® consists of four specialized modules designed to streamline regulatory compliance processes:
Automates systematic literature reviews with AI data extraction, automatic PDF download, and dedicated SoTa (State-of-the-art) workflow
Captures metadata, detects duplicates, and integrates PubMed & Google Scholar searches
Integrated with FDA MAUDE, TPLC, and other databases for comprehensive adverse event tracking
Ensures traceability and real-time monitoring of regulatory concerns
Centralized repository for managing regulatory source documents, templates, and references
Ensures accuracy in CERs, PERs, and PMCF reports
GenAI-powered content generation and predefined templates to maintain consistency across reports
Review workflow made simpler & faster with source content linking, simultaneous reviews, and status dashboards
Customizable Data Collection Forms – Automatically updated summary tables reduce manual input errors
Bulk Import of Search Data – Accelerates literature review and regulatory submission processes
Dynamic Literature Review Tables – Plug directly into final report deliverables such as CERs and PMCF reports, updating in real-time
Automated Audit Trails – Ensures traceability and compliance readiness for health agencies and Notified Bodies
CAPTIS® in Action: Self-Guided Demo
Walk through CAPTIS® Literature Module to see how it runs a new literature search, applies filters, and performs L1 screening.
View Demo
CAPTIS® AI Platform for EU MDR and IVDR Compliance
CAPTIS® is a secure, user-friendly web-based application that assists medical writers with the laborious process of creating regulatory documentation for EU MDR / IVDR compliance such as CEP/CER, PEP/PER, SVR, PMCF Plan/Report, SSCPs and more. CAPTIS® has been developed in collaboration with our experienced and qualified team of medical writers to address the real time challenges in medical writing and EU MDR / IVDR compliance.
Learn More About CAPTIS ®
Eliminates manual errors with automated duplicate detection, metadata capture, and advanced filtering.
Ensures traceability, auditability, and compliance with EU MDR, IVDR, MedDev 2.7/1 Rev. 4, and PRISMA guidelines.
Integrated workflows enable real-time collaboration between medical writers, reviewers, and regulatory teams.
Leverage Celegence’s proprietary platform to automate data extraction and reporting, improving efficiency across regulatory submissions.
Manager, Medical Device Services
Smridula Hariharan has a Master’s degree in Pharmacy, and over 12 years of experience in Medical Writing for Medical Device Regulatory Affairs as well as pharmacovigilance and clinical research.
She has authored and reviewed post-market surveillance (PMS) documents for medical devices and invitro diagnostics belonging to different risk classes and therapeutic areas.
She has successfully procured CE marking under MDD and MDR for novel as well as legacy products through comprehensive clinical evaluations, PMS plans, and PMCF plans/reports.
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Medical Writer II
Tamanna Sahraya is a skilled medical writer specializing in regulatory documentation for medical devices, with expertise in FDA and EU MDR compliance. She has experience authoring Clinical Evaluation Reports (CER), Post-Market Surveillance Reports (PMSR), and Risk-Benefit Assessments while ensuring adherence to MEDDEV 2.7/1 Rev. 4 and MDR standards.
With a strong background in regulatory affairs, literature reviews, and safety analysis, she supports product lifecycle management and clinical data reporting. Her analytical approach and commitment to compliance help streamline regulatory submissions and enhance client collaboration.
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Medical Writer II
Roderick Shilshi is a regulatory medical writer specializing in medical device compliance under FDA and EU MDR regulations. He has experience authoring Clinical Evaluation Reports (CER), Post-Market Surveillance Reports (PMSR), and Risk-Benefit Assessments, ensuring alignment with MEDDEV 2.7/1 Rev. 4 and MDR standards.
With expertise in literature reviews, safety reporting, and regulatory submissions, he supports product lifecycle management and clinical data analysis. His detail-oriented approach helps maintain compliance and streamline regulatory documentation.
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Senior Medical Writer
Srujana Akkiraju is an experienced medical writer with nearly a decade of expertise in regulatory and clinical documentation. She specializes in authoring and reviewing high-quality regulatory submissions, including CCDS, RMPs, PSURs, and labeling content across multiple therapeutic areas.
At Celegence, she leads a team of medical writers, ensuring compliance with global regulatory standards while optimizing processes for efficiency. With a strong background in scientific writing, quality control, and stakeholder collaboration, she plays a key role in delivering clear, precise, and regulatory-compliant documentation.
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25 Apr, 2025
25 Apr, 2025
25 Apr, 2025
From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence. Contact us to learn how we can help you achieve your compliance goals efficiently and cost-effectively.
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