Celegence provides the medical device and in-vitro diagnostics industries with consulting services and technology that are tailored to the evolving needs of manufacturers and global regulations.
Our suite of services includes end-to-end EU MDR and IVDR support, which we have been successfully delivering since the new regulations came out. With our guidance, bringing your devices to the market and keeping them there will be easier for your regulatory and quality teams.
Celegence has a wealth of knowledge to help you navigate through the complex challenges that Medical Device Regulation inherently brings. We can assist you throughout the entire process to ensure that you and your business are compliant with all global device requirements.
EU MDR Consulting Services
In-Vitro Diagnostic Services
MDR, IVDR, UDI process and strategy consulting
EUDAMED, PMS consulting
Business Process Definition & Optimization - UDI
Audit Services – Pharmacovigilance, Quality, Regulatory compliance readiness
Regulatory Intelligence Consulting
Strategic advisory consulting
EU Authorized Representative
510(k), PMA, DeNovo and global regulatory submissions
US, EU, Australian, Chinese, and Canadian documentation and technical file development.
Notified Body responses
Import and Export License applications
In country representation
Global Medical Device and IVD Registrations
BSI-certified mock audits
Assessment of equivalent devices
QMS audit support
Gap assessment and MDR / IVDR readiness plans
Technical file remediation
Compliance training for manufacturers
Literature search and review
CEP/CER, PEP/PER, and risk management - documentation development
CER/PER remediation from Rev 3 to Rev 4
PMCF Plans and Reports
PMSR, PSUR, SSCP, FSCA
Clinical Study Protocols and Reports
Health Hazard Evaluation and Risk Assessment
Protocol & Amendment Writing
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.
Introduction of AI into your regulatory operations brings significant efficiencies and cost savings, however, it’s important to find the right fit for it. From AI-powered turnkey deliverables to innovative transformation of compliance, we help companies leverage technology according to their needs.
Use the guide below to identify which model best matches your operational goals.
DIRECTOR OF REGULATORY SERVICES, Medical Device
Ramesh has significant experience in Medical Device and Invitro Diagnostic Devices, with more than 22 years’ experience in the Life Science Industry – specifically in NPD, PMS, QMS, and Regulatory Affairs.
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SME | Director, Medical Device
Joseph has 20 years experience in medical device life cycle management and quality management systems (certified to ISO 13485, ISO 9001 & ISO/IEC17025).
Key experience includes preparation and maintenance of technical files, product safety and vigilance reporting, clinical evaluations, risk assessment, regulatory audits, CE and notified body opinion submissions. Joseph has worked on diabetes management devices, nicotine replacement therapy (NRT) devices and pressurised metered dose inhalers (pMDI); Joseph has worked for small, medium and large Biotech companies such as Roche, OBG Pharmaceuticals and Kind Consumer Ltd.
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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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