Events

The future of medical device trials is being built on interoperable, high-quality data. In an effort to streamline processes and accelerate innovation, the Medical Device Innovation Consortium (MDIC), in partnership with the Clinical Data Interchange Standards Consortium (CDISC) and the FDA, is leading an initiative to develop data standards for in vitro diagnostic (IVD) devices.

This session, led by clinical data experts, will highlight the significant progress being made. The panel will share key insights from the recently published landscape analysis and discuss:

• Historical challenges and current state for the definition and adoption of standards
• Ongoing efforts between CDISC, FDA, MDIC, and the industry toward the creation of IVD clinical data standards
• What should be done to align global regulatory expectations to simplify the submission and review process

Join us to learn how these standardization efforts are creating an end-to-end harmonized platform that will shape the future of clinical trials for IVDs.

Speakers:

• Carey Smoak, Co-founder and Co-leader of the CDISC Device Team, Roche (retired)
• John Owen, Head, Project Management Office, CDISC
• Nick Decker, Head of Regulatory Policy, Roche

Moderator:

• John Acampado, MBA, MPH, PMI-ACP, Sr. Director Clinical Strategy, Veeva MedTech

Presented by: MDIC, Veeva MedTech, and CDISC Organized by: Medical Device Innovation Consortium

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The 2025 American Medical Device Summit is a platform where medical device innovation meets opportunity. Designed to unite over 250 medical device executives from top medical device companies and solution providers to exchange ideas and insights on industry trends such as wearable medical device trends, R&D, robotics, and artificial intelligence. Enjoy sessions led by pioneering MedDevice experts on accelerating product development and design, optimizing regulatory strategies, managing costs, and ensuring quality across medical device systems. Gain strategic insights from practical, real-world case studies focused on technological advancements, regulatory compliance, and navigating the global medtech landscape. Join Veeva MedTech for the following sessions:

• Plenary: Navigating the New Frontier – Leadership, AI, and a Culture of Quality in Regulatory Excellence
• Roundtable: Enabling an Agile and Efficient Culture of Quality
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The Competitive Advantage: Transforming Vision into Value Join us at the 2025 MDIC Excellence in Quality Summit, where leaders from across the medical device ecosystem will convene to explore how quality serves as a powerful driver of organizational success at every stage of the product lifecycle—from development to patient outcomes. Join Veeva MedTech at the following sessions and in the exhibit hall:

• To Recall or Not to Recall?
• Technology as an Enabler of Patient Safety
• Culture Fireside Chat with Thermo Fisher Scientific & BD
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Registration for Veeva MedTech Summit 2025 in Madrid is open. Summit is two days of networking and 40+ educational sessions covering topics across clinical, quality, regulatory, commercial, technology, and medical affairs. Register

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Jennifer Kerr, President at Cook Research, shares insight on how Cook Research is leveraging digital platforms to unify clinical operations and speed study execution, including:

Industry trends to improve clinical study performance

Factors that accelerate implementation

Achieving visibility, oversight, and collaboration

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B.Braun & Integra describe the future of patient care, how to reach a more diverse audience, and how to design patient-centric trials. Access Now

Becki Brasher, Medtronic, and Bassil Akra shares insights and best practices for managing claims, commercial content, and compliance, including:

Advertising regulations and risks

Ownership, substantiation, approval, and field compliance monitorization

Do’s and don'ts for a solid claims foundation

Accelerating speed to market and competitive advantage

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Medical Affairs is evolving and enabling fast, compliant, strategic engagement with HCPs and KOLs. Connectivity across channels is imperative to get products to patients and to understand their needs.

Join this webinar for insights on:

-Medical Affairs trends and challenges

-How top medtechs are adapting processes, roles, and approaches

-Driving efficiency and value across the organization leveraging technology

-Unifying scientific exchange, content, and intelligence with Veeva Medical Suite

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Join this webinar to learn how B.Braun modernized clinical management to speed trials and support global growth. You'll discover how their approach to modernizing trial management leverages cloud technology through phased implementation, robust digital frameworks, global process harmonization, and continuous change management to ensure success. Access Here

Ascensia Diabetes Care, Global Program Lead, Ntianu Onumonu will share how the company implemented a claims and content management program that reduces review and approval times, enhances compliance, and streamlines marketing operations.

Ntianu will share:

1. How to navigate organizational complexities
2. Critical steps of implementation and adoption How automation is reducing time in the review process
3. Practical advice to gradually improve claims and content with tangible results

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João Martins, Associate Director of Regulatory Affairs Strategy at Abbott, and Megha Deviprasad Iyer, Director of Global Strategic Regulatory Affairs at Thermo Fisher Scientific will address the growing challenges for regulatory affairs professionals amid increasing global health regulations and shifting priorities.

They will discuss:

1. Scaling resources to stay ahead of complex medtech regulations
2. Addressing the impact of evolving regulations on internal workflow and compliance strategies
3. Driving innovation and expediting product market entry

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Our recent benchmark study reveals the industry is being driven toward quality transformation by a need for proactive and scaleable quality management, rather than simply by compliance or regulatory changes. This industry shift creates new expectations for postmarket quality management. Watch a presentation of the key findings and insights into how to enable successful quality transformation, including: - Improved Governance: Establish stronger frameworks for quality management - Strategic Technology Adoption: Leverage modern solutions to drive efficiency and insights - Proactive Quality Practices: Shift from reactive issue management to prevention and innovation Access Now