Webinar: Navigating Clinical Evaluation Excellence: A Strategic Guide for Medical Devices

What: Webinar – “Navigating Clinical Evaluation Excellence: A Strategic Guide for Medical Devices”
When: Tuesday, December 5, 2023, 9:30 am Central US Time | 4:30 pm Central EU Time
Where: Online Event
How: Register Here
Why: Join us in this insightful webinar as we guide you through the art of crafting a winning strategy for conducting clinical evaluations on medical devices.

During this webinar, step by step, we’ll unveil the key components of building a robust Clinical Evaluation Report (CER), explore the treasure trove of internal and external data sources at your disposal, and shed light on the common areas closely scrutinized by Notified Bodies.

Moreover, we’ll reveal the transformative role of technology as an invaluable tool to streamline and enhance the efficiency of your entire evaluation process. Get ready to excel in the world of clinical evaluation and regulatory compliance.

This featured presentation will be led by Celegence’s Dr. Anushree Singh, Associate Manager, Medical Device Services and Parvathi Nambiar, Team Lead, Medical Device Services. Our panelists will also be available for a live Q&A session after the presentation.

Have a question now? Submit it ahead of time and we will endeavor to provide you with a live answer during our webinar, submit your question here.

Celegence will be hosting the WEBINAR on Tuesday, December 5, 2023, 9:30 am Central US Time. Register online now!

Dr. Anushree Singh, Associate Manager, Medical Device Services

• Anushree Singh has a Doctorate degree in Neuro-oncology and a master’s degree in Bioscience (Human Genetics), and an overall experience of 6 years working as a researcher and lecturer.
• She has authored and reviewed EU MDR compliant regulatory documents for medical devices covering a wide range of therapeutic areas – all specialties of dentistry, radiosurgery, diagnostic imaging, neuro-oncology, hemodialysis, female reproductive health, and pneumothorax pulmonology.
• At Celegence, she provides strategic advice to customers on regulatory strategy for clinical evaluation, Post-Market Surveillance including Post-Market Clinical Follow-up, and Clinical Evidence pathways.
• She leads a team of qualified medical writers, expert in clinical evaluation of simple-to-complex medical devices, authoring various regulatory documents such as Clinical Evaluation Plans and Reports, Post-Market Surveillance Plans and Reports, Summary of Safety and Clinical Performance, and Post-Market Clinical Follow-up Plans. Her team has successfully completed several projects related to addressing Notified Body observations (BSI, DEKRA, SGS, Eurofins Expert Services Oy) on the road to CE Marking of medical devices under EU MDR.

Parvathi Nambiar, Team Lead, Medical Device Services, Celegence

• Parvathi has a master’s degree in microbiology, and an overall 6 years of experience in Medical Writing for Pharma and Medical Device Regulatory Affairs. She has authored and reviewed post-market surveillance (PMS) documents and Clinical Investigation Plan (CIP) and Clinical Study Report (CSR).
• At Celegence, she leads a team of medical writers who work on CEPs, CERs, PMS Plan, Post-Market Surveillance Reports, Periodic Safety Update Reports, Post-Market Clinical Follow-up Plan and Reports, for devices belonging to a wide range of therapeutic areas including all specialties of dentistry, radiosurgery, diagnostic imaging, in vitro fertilization (IVF)/assisted reproductive technology (ART) devices, cardiac defibrillator, and female health products.

• This webinar is your roadmap to excellence in the world of clinical evaluations for medical devices.
• Join us to gain the knowledge and strategies needed to succeed in this critical aspect of regulatory compliance.

1. Develop a Comprehensive Clinical Evaluation Strategy:

• Learn how to construct a well-defined strategy for Clinical Evaluation, encompassing all essential elements.
• Understand the importance of aligning your strategy with regulatory requirements and best practices.

2. Master the Art of Data Sourcing:

• Discover the wealth of internal and external data sources available for robust clinical evaluations.
• Gain insights into how to effectively collect, analyze, and present this data in your Clinical Evaluation Report (CER).

3. Navigate Notified Body Scrutiny:

• Uncover the specific areas that Notified Bodies pay close attention to during the review process.
• Learn strategies to proactively address these areas and increase the chances of successful compliance.

4. Harness Technology for Efficiency:

• Explore how technology can be harnessed as an assistive tool to streamline and enhance the efficiency of your clinical evaluation process.
• Understand the role of technology in reducing administrative burden, improving accuracy, and ensuring compliance.

The webinar is intended for professionals of the medical device industry: Personal of Clinical Affairs, Regulatory Affairs, Quality Management and others involved in the Clinical Evaluation. This webinar is perfect for Top Management / VPs, R&D Managers, Medical Device Executives, Technical Writers and Managers and Medical Writers / Reviewers.

As a global regulatory solutions and services provider, Celegence can support your organization with EU MDR Gap Analysis, PMS Reporting, Clinical Documentation and Notified Body Interactions to achieve maximum compliance, save time and improve operational efficiency. Now is the time to start adoption of technologies like CAPTIS, our groundbreaking EU MDR & IVDR solution which increases efficiency of medical writers to ensure ongoing, sustained compliance.

For more information on how we can help you with EU MDR and IVDR requirements reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device services.

“Navigating Clinical Evaluation Excellence: A Strategic Guide for Medical Devices” webinar will be held on Tuesday, December 5, 2023, 9:30 am Central US Time. Make sure you secure your place at the webinar by registering now.