search
close_mark
Medical-service-banner

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.

Industry Leaders Trust Celegence

IVDR Challenges for regulatory teams

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

In-vitro diagnostic regulatory services

  • Icon

    Gap Assessments

    Expand
  • Icon

    Device re-classification as per IVDR (Classes A, B, C, D) IVDR Readiness

  • Icon

    Assessments & Mock Audits

  • Icon

    Technical Documentation and PMS

  • Icon

    QMS development and implementation

  • Icon

    Medical Writing, Post-Market Documentation

    Expand
  • Icon

    Performance Evaluation Plan (PEP) & Report (PER)

  • Icon

    Scientific Validity Report (SVR)

  • Icon

    Analytical Performance Report (APR)

  • Icon

    Clinical Performance Report (CPR)

  • Icon

    Global Registrations & Documentation

    Expand
  • Icon

    UDI and Labelling Requirements

  • Icon

    Technical File Creation

  • Icon

    Submission and Review

  • Icon

    CE-Marking and International Approvals

  • Icon

    IVD Experience

    Expand
  • Icon

    Companion Diagnostics

  • Icon

    Lab Developed Tests (LDTS)

  • Icon

    Point of Care Tests (POC)

  • Icon

    Instrumentation Lab Management Systems

  • Icon

    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 ®

Smarter PMS Documentation with

captis-img

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

img

Information Consistency

  • Modify entries across all documents with a single update.
  • Align data and content across various documents for simplified maintenance using Local and Global Data Dictionaries.
  • Predefine commonly used terms such as “Indication for Use” as dictionary entries to ensure consistency

Automated Abbreviations & Citations

img

Saving Half The Time

  • CAPTIS® automatically creates a list of abbreviations, updating as new entries are added and used.
  • The built-in Citation and Reference Manager automates the process of creating citations.
  • Eliminates need for EndNote, Mendeley, and Zotero subscriptions.
img

Content Linking & Traceability

img

Faster Reviews

Create a CAPTIS®Link:

  • Link to any content or information from a source document, such as an IFU.
  • Maintain traceability and save time when verifying report content. Quickly navigate to the original source documents to breeze through content verification

Stay Aligned with Collaboration & Review

img

Team Alignment

  • Work concurrently on various projects.
  • Communicate with your team and update project status with comments and responses.
  • Assign roles and responsibilities with customizable review
img

Inserting Automated Literature Report

img

Reduced Errors

  • Leverage automated, ready-to-use literature reports to present various elements from your literature review.
  • Eliminate manual updates as all data is automatically updated from CAPTIS® literature review module
img

Regulatory Software

Software Logo

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®

percentage-icon

62%

Data Gathering Reduction

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

percentage-icon

30%

Literature Review Reduction

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

percentage-icon

45%

Searching & Archiving

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

percentage-icon

100%

Article Deduplication

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

percentage-icon

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
speaker-profile

Manager, Medical Device Services​

Smridula Hariharan​

linked-in

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.

Read More

Read Less

speaker-profile

SME | Director, Medical Device

Joseph Richardson Larbi

linked-in

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.

Read More

Read Less

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.

"*" indicates required fields