AI and Automation for Regulatory Compliance in Medical Devices – Smarter Data Management Webinar

• When: Thursday, December 5, 2024 | 10:00 AM – 11:00 AM ET (US)
• Where: Online Event
• How: Register Here
• Why: In today’s evolving regulatory environment, medical device and IVD manufacturers face increasing demands to maintain compliance with stringent regulatory requirements. Staying ahead means adopting new technologies designed to streamline compliance efforts while ensuring accuracy, efficiency, and cost-effectiveness. In this session, we’ll explore the role of AI and automation in regulatory affairs and provide actionable insights into how these tools can enhance your regulatory processes.

As regulatory requirements grow more complex, medical device companies need smarter, more efficient ways to manage compliance. This webinar will explore the latest AI-powered solutions, demonstrating how technology can ease the burden of regulatory data management and improve the quality of submissions to authorities. By integrating AI, regulatory professionals can leverage data-driven insights to review, analyze, and populate technical dossiers with greater precision and speed.

The “AI and Automation for Regulatory Compliance” webinar is designed to equip attendees with practical knowledge and strategies for modernizing their compliance approach. Key learning objectives include:

• Exploring Technology Solutions: Discover the latest advancements in regulatory compliance technology and learn how AI-powered tools can optimize the review and population of technical dossiers.
• Benefits of AI in Regulatory Affairs: Understand how AI can transform the preparation of technical and clinical data required by authorities, driving process efficiencies and optimizing data accuracy.
• Regulatory Expectations and Best Practices: Gain insight into regulatory authorities’ expectations and best practices for presenting clinical data, ensuring your technical files meet compliance standards.

The webinar will feature presentations from two industry experts with extensive experience in regulatory affairs and medical device compliance:

• Shruti Sharma, Product Specialist for Celegence’s CAPTIS™ platform, brings a wealth of knowledge in Clinical Evaluations for Medical Devices across diverse therapeutic areas. With over 7 years in regulatory affairs, she specializes in crafting MDR-compliant documents, including CEPs, CERs, PMSRs, and SSCPs, tailored to meet the specific needs of medical device manufacturers.
• Joseph Richardson Larbi, Director and Medical Device Subject Matter Expert at Celegence, has over two decades of expertise in the lifecycle management of medical devices and IVDs, covering a range of areas from research to post-market surveillance. His proficiency spans multiple therapeutic areas, including diabetes, ophthalmology, nicotine replacement therapy, and ECMO.

This webinar is ideal for regulatory affairs decision-makers in the medical device, IVD, and pharmaceutical sectors. Professionals in roles such as Regulatory Affairs Directors and Quality Assurance Directors will benefit from this session’s focus on technology-driven efficiencies and best practices for regulatory compliance.

Don’t miss the opportunity to learn how AI and automation can simplify your approach to regulatory compliance. This webinar offers actionable insights and practical strategies for navigating regulatory demands in an increasingly complex landscape.

As a leading global regulatory solutions and services provider, Celegence is dedicated to supporting your organization in achieving maximum compliance with EU MDR regulations. Our comprehensive and technology-enabled services include EU MDR Gap Analysis, PMS Reporting, Clinical Documentation, and Notified Body Interactions, designed to streamline your processes, save time, and enhance operational efficiency.

Now is the ideal time to embrace innovative technologies such as CAPTIS™, our groundbreaking EU MDR & IVDR solution. CAPTIS empowers medical writers by increasing efficiency, ensuring ongoing compliance, and facilitating seamless adaptation to regulatory requirements. With Celegence and CAPTIS by your side, you can confidently navigate the complexities of EU MDR compliance and drive sustainable success in the medical device industry. Embark on your journey towards regulatory excellence with Celegence today.

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 excited to share our insights with you during this webinar and look forward to connecting with you on December 5!

Register today and step into the future of regulatory compliance.