Leveraging Technology to Optimize MDR Compliance Outsourcing and Partnership

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Overview What You Will Learn Webinar Speakers

Overview

Leveraging Technology to Optimize MDR Compliance Outsourcing and Partnership – Webinar

Where

Online

When

10:00 AM EST

Webinar Background

Across the medical device and diagnostics industry, there are common obstacles when producing compliant Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs) and other PMS related documentation in an efficient manner.

With the overall expansion of requirements for EU market access, PMS documentation now takes far longer and requires more medical writers and reviewers to work on the same materials (articles, source documents, adverse event data, etc.) simultaneously.

Systematic literature searches were especially difficult using previous research practices, with consistent citations becoming especially inefficient and time-consuming. Manual workflows take hundreds of hours a month and slow down the creation and maintenance of documentation, which can place massive burdens on a medical writing team.

Leveraging technology solutions and PMS documentation process automation will save medical writing teams hundreds of hours of manual effort as well as significantly reduce the propensity for human error, improving the quality of your outputs.

You’ll learn how CAPTIS™ – our exclusive technology for EU MDR/IVDR compliance, helps to produce high-quality, sustainable, cost-effective, error-free and audit-ready systematic literature reviews for the device and diagnostic industry.

Webinar Focus

This webinar will cover the key benefits of outsourcing EU MDR & IVDR compliant documentation projects to Celegence and how CAPTIS compliance software directly addresses major challenges.

We will cover key automation features offered by CAPTIS including:

Easy collaboration & real-time reviews
Easy implementation of mid-project process changes
Content management, data ownership and access control
SoTA workflow

What You Will Learn

Webinar Learning Objectives

Working effectively with outsourced requirements and forming long-lasting partnerships
Learn how to utilize automation software for faster, smarter and more cost-effective report development and maintenance
Better understand how CAPTIS reduces the time it takes to author your PMS documentation by nearly 30%
Have your most pressing questions answered during the Q/A session

Webinar Speakers

Manager, Medical Device Services, Celegence

Smridula Hariharan

9 years of medical writing experience including Medical Devices and In vitro diagnostics Experience spanning different therapeutic areas and all medical device risk classes

Clinical Regulatory Affairs Specialist (Medical Writer), Acumed

Kim Carlson Banning, PhD

Post-doctoral research experience in Biochemistry and Molecular Biology Scientific Research and Medical Writing experience spanning 15+ years

Who Should Attend?

This webinar is aimed towards those working for companies in the life sciences industry, particularly manufacturers of medical devices & IVDs, with a special emphasis on:

Regulatory Affairs Professionals
Quality Assurance Professionals
Medical Device Executives
Technical Writers and Managers
Medical Device Design Managers
Clinical Managers