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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.

Medical Device Services

Medical Device Services

In-Vitro Diagnostic Services

In-Vitro Diagnostic Services

Industry Leaders Trust Celegence

Medical Device & IVD Division

Efficiency

  • Proprietary software platform to increase efficiency in medical writing and improve oversight
  • Minimal to no lead time in project ramp up
  • Effective Communication: Single point of contact project management model.

Cost Reduction

  • Predictable Total Cost of Ownership (TCO) with cost effective services
  • Competitive pricing allowing you to reduce costs on average by ~20% for RA/QA support services
  • Dedicated resource pool, lowering the Total Cost of Ownership

Experience

  • 99% First Time CER acceptance by Notified Bodies
  • All Project Leads have a Masters or a phD
  • Consultation from Industry Leaders, many from Notified Bodies, with decades of experience
  • Vast experience in every major market – and nearly all emerging markets

Flexibility & Trust

  • Partnerships with 3 of the top 10 Life Science Companies Globally
  • SLA driven metrics- indemnifi cation-insured performance and quality
  • ISO 9001:2008 & ISO 27001:2015 certified

Medical Device & IVD Services

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    MD and IVD Regulatory Consulting Services

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    MDR, IVDR, UDI process and strategy consulting

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    CEUDAMED, PMS consulting

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    Business Process Definition & Optimization - UDI

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    Audit Services – Pharmacovigilance, Quality, Regulatory compliance readiness

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    Regulatory Intelligence Consulting

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    Strategic advisory consulting

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    EU Authorized Representative

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    Regulatory Intelligence

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    Regulatory Submissions

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    510(k), PMA, DeNovo and global regulatory submissions

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    US, EU, Australian, Chinese, and Canadian documentation and technical file development.

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    Notified Body responses

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    Import and Export License applications

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    In country representation

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    Global Medical Device and IVD Registrations

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    Gap Assessment & Audit Support

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    BSI-certified mock audits

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    Assessment of equivalent devices

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    QMS audit support

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    Gap assessment and MDR / IVDR readiness plans

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    Technical file remediation

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    Compliance training for manufacturers

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    Documentation and Report Writing

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    Literature search and review

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    CEP/CER, PEP/PER, and risk management - documentation development

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    CER/PER remediation from Rev 3 to Rev 4

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    PMCF Plans and Reports

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    PMSR, PSUR, SSCP, FSCA

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    Clinical Study Protocols and Reports

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    Health Hazard Evaluation and Risk Assessment

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    Protocol & Amendment Writing

Regulatory Software

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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.

Time savings with CAPTIS®

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62%

Data Gathering Reduction

CAPTIS utilization resulted in a 62% reduction of time in data gathering tasks.

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30%

Literature Review Reduction

Overall reduction of nearly 30% of time in systematic literature review

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45%

Searching & Archiving

45% time savings in searching and archiving full-text articles using CAPTIS

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100%

Article Deduplication

Users saved 100% of time because duplicates are detected automatically.

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13:16 HOURS

Literature Review Time Reduction

Overall savings of 13 hours and 16 minutes from each literature review.

Meet The Team

  • All our project leads have a Master’s degree in a relevant field
  • All have 10+ years of experience in Pharmaceutical Regulatory domain
  • Experienced supporting regulatory strategy in 50+ countries
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DIRECTOR OF REGULATORY SERVICES, Medical Device

Ramesh Annayappa

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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 Richardson Larbi

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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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Contact Us Today

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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