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 | Addressing 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. |
Download our EU MDR checklist for actionable technical documentation requirements. The checklist highlights all the key areas that you need to be aware of.
6 Weeks
Average CER turnaround time
30%
Quicker CERs with CAPTIS® MDR/IVDR AI platform
+60%
Faster SLRs compared to manual reviews
99%
First-Time Acceptance Rate by Notified Bodies
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 CAPTISCAPTIS® 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, RA/QA
“I would highly recommend Celegence for any EU MDR compliance related projects.
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. Similarly, the CER prepared was top notch with all of the appropriate hooks in place to allow compliance with the new EU MDR. All in all, I would highly recommend Celegence for any EU MDR compliance related projects.”
VP Quality & Regulatory Affairs
“We had a very good experience working alongside the Celegence medical device services team when drafting our clinical evaluation processes, and truly appreciate their highly professional and cooperative global regulatory experts. They took great care in understanding our CER/CEP and PSUR submission requirements.”
Technology Integration Lead, 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 panelist on webinars in association with MTI and Q1 Productions, on topics related to Clinical Evaluation.
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Senior Manager, IVD & Complaints Management
Smridula holds a Master’s degree in Pharmacy and brings 13+ years of experience in medical device regulatory writing, pharmacovigilance, and clinical research.
She supports global manufacturers across MDR and IVDR compliance through strategic regulatory and safety expertise.
Smridula provides deep expertise in safety database analysis, signal detection, and complaint handling to support regulatory compliance and patient safety.
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Manager/Senior SME, Medical Device Services
Rohan Sathe holds an M. Tech in Biomedical Engineering from IIT Bombay and has over 10 years of experience in the medical device and clinical trial industry. He specializes in the preparation and review of Clinical Evaluation Reports (CERs) across multiple therapeutic areas.
His expertise includes EU MDR clinical evaluation, Software as a Medical Device (SaMD), Biostatistics, Post-Market Surveillance (PMS), and Post-Market Clinical Follow-up (PMCF), along with addressing Notified Body observations.
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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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