Celegence is a global life science consulting firm focused solely on regulatory and quality compliance. We have the expertise to provide support for all of your In-Vitro Diagnostic (IVD) regulatory needs; from strategic consulting, registration, device classification, PERs, to in country representation.
Celegence is entrusted by 3 of the Top 10 leading Life Science companies to support their regulatory initiatives and provide strategic guidance. We have expertise and know-how to navigate the complex regulations on a global scale, supporting all stages and risk classifications.
With introduction of EU In-Vitro Diagnostic Regulations, In-Vitro Diagnostic manufacturers in the European marketplace have faced many challenges navigating the new landscape, staying compliant, and managing internal resources needed to adhere to the new regulations. We help our clients overcome these challenges, meet their deadlines, and save costs.
Transition Strategy
With less time in hand to shift from IVDD to IVDR, it is necessary to have a proven strategy. Begin by sorting out the confusion and choosing the relevant Notified Body. Bring all the evidences together.
Prioritization of Product Portfolio
Scrutinize each of your devices and assess them depending on the part they play in the entire product portfolio of the company. Keep in mind the surging clinical and regulatory costs.
Documentation & Labeling Updates
Under the IVDR (Annex II & III) provides the list of content needed as part of technical documentation for each product. Supply chain complexities within IVDR designate each distributor as “economic operators” and they would be vested with regulatory and legal responsibilities.
Interpretation of Requirements
The main aim behind all these changes is to establish a "quality management system." If you are trying to operate within the EU then it is high time to ensure that you are compliant with EN ISO 13485:2016
Device re-classification as per IVDR (Classes A, B, C, D) IVDR Readiness
Assessments & Mock Audits
Technical Documentation and PMS
QMS development and implementation
Performance Evaluation Plan (PEP) & Report (PER)
Scientific Validity Report (SVR)
Analytical Performance Report (APR)
Clinical Performance Report (CPR)
UDI and Labelling Requirements
Technical File Creation
Submission and Review
CE-Marking and International Approvals
Companion Diagnostics
Lab Developed Tests (LDTS)
Point of Care Tests (POC)
Instrumentation Lab Management Systems
Molecular Diagnostics
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 ®
Experience the power of CAPTIS®, with its groundbreaking Document Creation & Maintenance Module.
Celegence team has extensive experience writing EU MDR & IVDR compliant documentation. Based on this experience, we have built a groundbreaking proprietary technology solution, CAPTIS®, to streamline MDR & IVDR document creation & maintenance.
Data Dictionary
Automated Abbreviations & Citations
Content Linking & Traceability
Create a CAPTIS®Link:
Stay Aligned with Collaboration & Review
Inserting Automated Literature Report
MDR/IVDR Compliance Solution
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.
Celegence team has extensive experience writing EU MDR & IVDR compliant documentation. Based on this experience, we have built a groundbreaking proprietary technology solution, CAPTIS®, to streamline MDR & IVDR document creation & maintenance.
62%
CAPTIS utilization resulted in a 62% reduction of time in data gathering tasks.
30%
Overall reduction of nearly 30% of time in systematic literature review
45%
45% time savings in searching and archiving full-text articles using CAPTIS
100%
Users saved 100% of time because duplicates are detected automatically.
13:16 HOURS
Overall savings of 13 hours and 16 minutes from each literature review.
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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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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