Regulatory Intelligence Management Summit 2024 – MTI

Celegence invites you to join us for the MTI Regulatory Intelligence Management Summit in Washington DC from June 3-5, 2024. Meet our experienced team at the summit where we will showcase our latest tech-enabled, AI-infused solutions and share our unparalleled expertise, designed to streamline regulatory processes, minimize expenses, and elevate compliance standards.

The Summit will cover a variety of discussions including the latest conversations in Risk Management, aligning with current FDA Strategic Priorities, RWD/RWE, AI/ML, Simulation, and Digital Twins! Join your industry colleagues and regulatory thought leaders by registering for the MTI Regulatory Intelligence Management Summit!

• When: June 3-5, 2024
  • June 3, Noon-5:00 pm – Optional Pre-Conference Workshops (FREE with your Summit Registration)
  • June 4, 8:30-5:00 pm – Summit General Sessions (Networking Reception 6:00pm)
  • June 5, 8:30-4:00 pm – Summit General Sessions
• Where: Conference Facilities at the Law Offices of Hogan Lovells located at 555 13th Street NW, Washington, DCUSA
• How To Register: Register Here
• Why: This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees.

Celegence is excited to be an exhibitor during this year’s Medical Device Regulatory Intelligence Summit in Washington DC. We will have the following Pre-conference workshop, TechTalks, and other sessions:

Pre-conference Workshop: Leveraging Post-Market Clinical Follow-Up (PMCF) Data for Monitoring Safety and Performance of your Medical Device

• When: June 3, 2024, 12:45 PM – 2:45 PM
• Speaker: Dr Pratibha Mishra, Manager and Sr. SME, Medical Device Services, Celegence

This workshop educates participants to develop and execute a PMCF plan as part of their post-market surveillance (PMS) obligations to mitigate risks of non-compliance and potential regulatory sanctions. Learn more about the Overview of PMCF requirements and its role in assessing device safety/performance; examine data collection methods, strengths, and limitations. Strategies for mitigating PMCF data collection challenges like follow-up, completeness, and bias. Analyzing/interpreting PMCF data for risk assessment, labeling, design changes, PMS strategies; case studies. Best practices for PMCF planning based on notified body reviews; and interactive exercises.
→ Register for this Workshop

Networking Lunch & TechTalk (Systematic Literature Review)

• When: June 4, 2024, 12:30 PM – 1:30 PM,
• Speaker: Dr Pratibha Mishra, Manager and Sr. SME, Medical Device Services, Celegence

→ Register for TechTalk

Optimizing Medical Device Life Cycle Management: Navigating Regulatory Pitfalls and Enhancing Compliance Across Global Markets

• When: June 5, 2024 9:20 AM – 9:55 AM
• Speakers: Joy Greidanus, Director, Medical Device SME, and Dr Pratibha Mishra, Manager and Sr. SME, Medical Device Services, Celegence

In this seminar, our experts will explore the gaps regulators commonly observe in medical device lifecycle management processes. They will provide insights on how manufacturers can enhance practices to mitigate risks and ensure compliance across major markets. The experts will also cover practical strategies and best practices for navigating regulatory complexities from design through post-market surveillance throughout the product lifecycle. With the help of real-world examples, they aim to help attendees optimize regulatory strategies and drive operational excellence in medical device manufacturing.
→ Register for this Seminar

This Summit explores the driving forces behind major regulatory changes and how digital transformation impacts Regulatory Intelligence and medical device compliance throughout product lifecycles. Advanced technologies fostering healthcare consumerism, with patients recognizing responsibility for their health, have led to an industry focus on improving care access and outcomes. The Summit provides insights into the reasons for recent regulatory shifts and potential future developments.

Presented by MedTech Intelligence, this intimate Summit helps regulatory leaders understand trends, challenges, and solutions impacting medical device regulatory processes and product compliance. Sessions cover the evolving global regulatory landscape, integrating new technologies into quality systems, and navigating regulatory pathways. Panels, workshops, and networking provide actionable takeaways for efficient, sustainable regulatory compliance and profitable product management.

Celegence, led by Sonia Veluchamy provides the medical device industry with consulting services and technology solutions that are tailored to the evolving operational and strategic needs of manufacturers in areas such as PMCF guidance, EU MDR gap analysis, PMS, Medical Device Consulting, and many more. We can assist you throughout the entire product life cycle to ensure that you and your organization are compliant with all medical device regulatory requirements.

Download the latest brochure of our full suite of compliance services for the Medical Device Industry.