Celegence provides comprehensive Clinical Evaluation Reports (CERs) to support EU MDR compliance for medical device manufacturers. With a team of seasoned regulatory experts and AI-powered automation, we deliver high-quality, audit-ready CERs with efficiency and accuracy.
Our expertise spans diverse therapeutic areas, and we tailor our approach to each client’s needs, ensuring that CERs are scientifically robust, regulatory-compliant, and efficiently delivered. Whether your device requires an initial CER, periodic updates, or a response to Notified Body feedback, Celegence ensures compliance without the burden of excessive revisions.
| CER Writing & Updates | Development of new CERs or updates to existing reports, ensuring alignment with EU MDR requirements and MedDev 2.7/1 Rev. 4. |
| Systematic Literature Review (SLR) | AI-powered, high-quality literature searches for clinical data analysis, reducing review time by 50%. |
| Clinical Data Appraisal & Gap Analysis | Comprehensive assessment of available clinical data, risk-benefit analysis, and identification of data gaps. |
| State-of-the-Art (SOTA) Development | Ensures SOTA documentation is up to date, capturing current industry standards and clinical practices. |
| Notified Body & Regulatory Support | IAddressing regulatory authority and Notified Body queries with well-documented, data-backed responses. |
| Post-Market Surveillance (PMS) & PMCF Alignment | CER integration with PMS, PMCF, SSCP, and PSUR documentation for consistency across submissions. |
Make Sure You’re EU MDR Compliant
Download our EU MDR checklist for actionable technical documentation requirements. The checklist highlights all the key areas that you need to be aware of and serves as a guide to help get you EU MDR compliant.
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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 ®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.
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Vice President, Regulatory Affairs & Quality Management Systems, Circle Cardiovascular Imaging
“I want to thank your team for the valuable contribution and partnership during this project. It’s noteworthy to mention that the clinical assessment phase was passed the BSI assessment without any questions / additional information being asked. This is primarily the CER/CEP evaluation and risk assessment. Thank you the entire “Celegence Team” for the timely delivery of quality work which is continue to be accepted by EU Notified Bodies.”
Vice President, RA/QA, Zap Surgical
“I reached out to Celegence to help my company prepare for an upcoming MDR assessment for CE Certification in late April. The timeline was very short and the deliverables requested were substantial. We needed a rewrite of our Clinical Evaluation Report (CER) as well as a Gap Analysis of our Technical Documentation to the new EU MDR within 2 months. The feedback was very detailed and actionable allowing us to quickly address all deficiencies within a week.”
Associate Manager, Medical Device Services
Parvathi Nambiar has a Master’s degree in Microbiology and over seven years’ experience in medical writing for pharmaceutical and medical device regulatory affairs. She has authored and reviewed clinical evaluation documentation, post-market surveillance (PMS) documents, Clinical Investigation Plans (CIP), and Clinical Study Reports (CSR).
A subject matter expert at Celegence, she leads a team of medical writers who work on CEPs, CERs, PMS plans, Post-Market Surveillance reports, Periodic Safety Update reports, Post-Market Clinical Follow-up plans, and reports, for devices from a wide range of therapeutic areas including all specialties of dentistry, radiosurgery, diagnostic imaging, in vitro fertilization (IVF)/assisted reproductive technology (ART) devices, cardiac defibrillator, implants, pulmonary, and female health products. She has successfully addressed feedback from Notified Bodies like BSI, Intertek, DEKRA, and achieved MDR certification for new devices and MDD certified devices. She has also been a panellist on webinars in association with MTI and Q1 Productions, on topics related to Clinical Evaluation.
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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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Team Lead - Medical Device Services
Over 9 years of expertise in the medical device and clinical trial industry, specializes in creating and reviewing Clinical Evaluation Reports (CERs) across various device classes and therapeutic areas.
Extensive experience in Software as a Medical Device (SaMD), Biostatistics, Post Market Surveillance (PMS), and Post Market Clinical Follow-up (PMCF).
Led multiple client projects, managed cross-functional teams, and provided resolutions to Notified Body observations.
Skilled in collaborating with regulatory affairs, clinical affairs, and quality assurance to ensure successful medical device development and compliance.
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15 Apr, 2025
26 Feb, 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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