Managing Global Regulatory Strategy and Compliance – Assessing Status, Gaps, and Needs

What: Webinar in partnership with Medtech Intelligence – “Webinar: Managing Global Regulatory Strategy and Compliance – Assessing Status, Gaps, and Needs”

When: Wednesday, July 31, 2024 | 12:00 PM – 1:00 PM ET US [UTC 5:00]

Where: Online Event

How: Register Here

In today’s fast-evolving regulatory environment, maintaining a robust global regulatory strategy and ensuring compliance is more critical than ever. A recent regulatory audience survey, conducted in partnership with Medtech Intelligence (MTI), revealed significant gaps in regulatory expertise and compliance processes within the medical device industry. Only 6% of respondents reported comprehensive regulatory expertise and processes, while nearly one-third indicated adequate processes but insufficient comprehension of changing requirements.

This upcoming webinar will address these pressing challenges. Our panel of industry experts will explore the findings of recent research, explore the shifting regulatory landscapes, and identify critical gaps. They will also share valuable insights on how to enhance regulatory intelligence and mitigate compliance deficits through knowledge, technology, and resources.

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 Wednesday, July 31, 2024, 12:00 pm ET. Register online now!

• Identify Regulatory Gaps: Understand why gaps in regulatory intelligence and compliance processes are overwhelming for teams and organizations.
• Risk Mitigation: Learn strategies to mitigate risks associated with the growing complexities of global regulatory compliance.
• Focus Areas: Discover where to prioritize MDR/IVDR efforts and investments.
• Technology and Resources: Explore technologies and resources for cost-effective management of current bandwidth limitations in the industry.

• Dr. Pratibha Mishra, Senior Manager – Medical Device Services, Celegence
• Erin Cosgrove, VP, Business Development – Medical Devices, Celegence
• Ibim Tariah, Ph.D., Technical Director – Medical Devices, SGS North America Inc.
• Gregory Jacobson, Sales Director – Medical Devices, SGS North America Inc.

• Rich West, Editorial Director & Publisher, MedTech Intelligence

This webinar is essential for Medical Device Leadership, Senior Product Managers, Regulatory Affairs/Quality Assurance Managers, Product Development & Design Teams, Manufacturing/Operations Leaders, and Human Resources and Finance Leadership.

Don’t miss out on this opportunity to gain crucial insights into managing global regulatory strategy and compliance. Register Now to secure your spot and join industry leaders in addressing the challenges and opportunities in the medical device regulatory landscape.

Celegence is dedicated to providing the expertise and technology needed to navigate the complexities of regulatory compliance. Join us and ensure your organization is equipped with the knowledge and tools to stay ahead in this dynamic industry.

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

Now is the perfect time to leverage innovative technologies such as CAPTIS™, our groundbreaking EU MDR & IVDR solution. CAPTIS™ increases efficiency for medical writers, ensures ongoing compliance, and facilitates seamless adaptation to regulatory requirements. With Celegence and CAPTIS™, you can confidently navigate the complexities of EU MDR and IVDR compliance and achieve sustainable success in the medical device and IVD industry.

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.