Celegence specializes in delivering EU MDR services with exceptional speed and quality. Since the introduction of the EU MDR regulations, we have developed and successfully applied innovative AI technology with built-in MDR compliance to greatly boost the efficiency of our medical writing teams. This adoption of AI technologies not only accelerates compliance but also delivers significant cost savings for our customers.
We align our strategy to specific devices and target markets, ensuring optimal outcomes. With our advanced in-house AI tools, our regulatory scientific writers expertly manage comprehensive medical device submissions and MDR maintenance, including Clinical Evaluation Reports (CERs) with remarkably fast turnaround times. Our in-depth knowledge of regulations and cutting-edge technology enables us to expedite the medical device registration and submission process without compromising quality and allowing our customers to focus on their core business.
60%
Time savings on Systematic Literature Reviews
30%
Faster Clinical Evaluation Report turnaround time
99%
First-time acceptance rate from Notified Bodies
10%
Cost savings on CERs
Manufacturers receiving observations from notified bodies can avoid further delays by consulting an experienced regulatory service provider to deal with such documents as 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.
Celegence has a wealth of knowledge to help manufacturers navigate through complex regulatory challenges. We assist with the selection of new NB, support audits, assist in authoring responses to the competent authority or NB, and subsequently expedite market access for clients' Medical Devices.
We examine the current status of your company’s regulatory affairs, with a focus on your procedures, processes, and CE technical documentation. A thorough gap analysis is paramount, and it will offer strategic dividends in the future with your upcoming clinical activities.
Manufacturers located outside of EU need to appoint a Europe-based Authorized Representative (AR) in order to place a medical device on the EU market. If you are a manufacturer in a 3rd country, Celegence can act as your Authorized Representative to access and maintain your product on the EU market or UKRP for United Kingdom.
Under EU MDR, all manufacturers require advanced PMS systems, processes, and personnel to manage these requirements. With our help, your PMS reports become far more manageable for your team.
CERs, especially literature reviews, are the most time-consuming portion of the Technical Documentation for the regulatory teams. With our in-house AI platform, we are able to deliver CERs 30% faster and with higher quality while cutting clients costs by at least 20%.
PMCF plays a vital role in managing the complete lifecycle of medical devices and is a key component of the Post-Market Surveillance (PMS), required for medical devices under the EU MDR. We help design the plan, conduct the study, and write supporting documentation
With our support, organizations are be able to maintain compliance through a single, all-encompassing UDI system, as required under MDR.
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 ®
Senior Manager, Medical Device Services
Dr. Pratibha has a Master’s degree in Oral Medicine and Maxillofacial Radiology and has previously worked as a clinician and lecturer. She specializes in clinical evaluation of simple-to-complex medical devices, including combination products, and medical device software. She has authored and reviewed templates and regulatory documentation for medical devices covering a wide range of therapeutic areas.
In her role as subject matter expert, she provides strategic advice to customers on regulatory strategy for clinical evaluation, post market surveillance including post market follow-up, and clinical evidence pathways. She leads a team of qualified medical writers in clinical evaluation of simple-to-complex medical devices, including medical device software. Her team has successfully completed several projects related to addressing observations from Notified Bodies (BSI, TÜV SÜD, Intertek, GMED, and DEKRA) on the road to CE Marking of medical devices under EU MDR.
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Manager/Senior SME, Medical Device Services
Dr. Ipshita Chattopadhyaya is a regulatory affairs expert with over eight years of experience, specializing in medical devices. She has extensive expertise in clinical evaluation and compliance with EU MDR 2017/745, covering a range of therapeutic areas, including ophthalmology, orthopedics, and hematology.
At Celegence, she leads the development and review of high-quality regulatory documents, ensuring compliance with MEDDEV 2.7/1 Rev. 4 and MDR requirements. She is also experienced in systematic literature reviews, risk management, and post-market surveillance.
Dr. Chattopadhyaya holds a Ph.D. in Pharmaceutical Sciences and has authored scientific publications in leading journals. Her regulatory knowledge and industry experience enable her to provide strategic guidance on medical device compliance and regulatory submissions.
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Manager, Medical Device Services
Dr. Anushree Singh has a Doctorate degree in Neuro-oncology and a Master's degree in Bioscience (Human Genetics). She has 13 years' experience in the Life Sciences Industry including 5 years' experience in Regulatory Writing for Medical Devices. She has authored and reviewed EU MDR compliant regulatory documents for medical devices covering a wide range of therapeutic areas.
At Celegence, she provides strategic advice to customers on regulatory strategy for clinical evaluation, Post-Market Surveillance (PMS) and Clinical Evidence pathways. She leads a team of qualified medical writers, expert in clinical evaluation of simple-to-complex medical devices, authoring various regulatory documents.
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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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Director, Medical Device Regulatory Affairs
Joseph has two and a half decades' experience in Medical Device life cycle management and Quality Management Systems (compliant with ISO 13485, ISO 9001 & ISO/IEC17025). Key experience covers drafting, remediating and maintaining EU MDR Technical Files, Medical Device Manufacturing, Safety and Vigilance Reporting, Regulatory and Quality Audits, CE and Notified Body Opinion Submissions.
Joseph has extensive knowledge and experience in working with Medical Devices, IVDs and Combination Products in various therapeutic areas including but not limited to: Diabetes, Respiratory and Nicotine Replacement Therapy (NRT), Infectious, Mental Health, Ophthalmology and Cardiovascular
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Enable unique identification of devices and to facilitate their traceability
Enable the public to be adequately informed about clinical investigations
Enable manufacturers to comply with vigilance, trending, analysis and reporting obligations of the MDR (Tool)
Enhance cooperation between competent authorities and the EU Commission
Enable the public to be adequately informed about
| Electronic System | EC Module Ref |
|---|---|
| 1. Registration of Economic Operators | 1. Actors Registration Module |
| 2. UDI Database | 2. UDI Devices Registration Module |
| 3. Registration of Devices | |
| 4. Notified Bodies and Certificates | 3. Notified Bodies Certificates Modules |
| 5. Clinical Investigations | 4. Clinical Investigations and Performance Studies Module |
| 6. Vigilance and Post Market Surveillance | 5. Vigilance and Post Market Surveillance |
| 7. Market Surveillance | 6. Market Surveillance |
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26 May, 2025
20 May, 2025
15 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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