Leveraging Technology to Optimize MDR Compliance Outsourcing and Partnership

• What: This is a webinar showcasing how our partnership with Acumed benefited from the usage of our CAPTIS solution. We will be discussing how medical device organizations can achieve efficiency, save time and improve accuracy by incorporating automation into their systematic literature review and Post-Market Surveillance (PMS) document creation processes.
• When: June 29^th, 2023, 10.00 – 11:00 ET
• Where: Online Event
• How: Register Here
• Why: Learn how to work efficiently alongside an external partner for MDR/IVDR compliance and explore the benefits of integrating exclusive technology designed to automate your literature and PMS documentation workflows.

This featured presentation will be led by a Celegence customer – Kim Carlson Banning, PhD from Acumed, and will be moderated by Celegence’s Manager for Medical Device Services, Smridula Hariharan. Our panelists will also be available for a live Q&A session after the presentation.

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.

Smridula Hariharan

Manager, Medical Device Services, Celegence

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

Kim Carlson Banning, PhD

Clinical Regulatory Affairs Specialist (Medical Writer), Acumed

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

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

• 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

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

Leveraging Technology to Optimize MDR Compliance Outsourcing and Partnership webinar will be held on Thursday, June 29^th at 10:00 AM ET. Make sure you secure your spot at the webinar by registering now.

Celegence – Regulatory Services and Solutions to Support the Medical Devices and Diagnostic Industry

To learn more about our cost-effective software solution, CAPTIS, dedicated to EU MDR/IVDR compliance, reach out to info@celegence.com or contact us online to schedule a demo! We are happy to share our insights with you during this webinar and hope that you can join us then.