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Digital Health


Upcoming Events & Webinars

- Open for Registration.
- Complimentary

More events coming soon!

On Demand Webinars

December 1, 2025
From Silos to Synergy: Building the Intelligent MedTech Lifecycle

Watch to explore how a connected, intelligent approach to the product lifecycle—powered by AI—can unlock new levels of operational excellence, spark innovation, and drive long-term value in MedTech.

September 17, 2025
Japan Medical Device Reimbursement Strategy

Japan’s reimbursement system can make or break a foreign medical device’s commercial success. This webinar goes into how reimbursement really works in Japan, from navigating functional reimbursement categories, dealing with Foreign Reference Pricing (FRP), building a cost-effectiveness case, clinical requirements, and mobilizing academic societies and KOLs to support higher pricing.

February 26, 2025
Are you talking to me? Communicating effectively with your Notified Body for an Accountable and Sustainable Working Relationship

EU MDR/IVDR conformity assessments are long-term projects that require a strong and sustainable partnership with a Notified Body. Manufacturers can significantly influence both the outcome and overall experience of the process by maintaining effective communication with the Notified Body personnel. Establishing a balanced and professional dynamic, where accountability is upheld without coming across as overly assertive or overly passive, is key to success.

January 21, 2025
Medical Device Labeling Best Practice for 2025: The Global Design Master

A forward-thinking webinar tailored for labeling and regulatory professionals in the medical device and pharmaceutical industries. Gain key insights into the latest strategies, tools, and best practices needed to elevate your labeling processes, ensure compliance, enhance speed-to-market, and improve cross-functional visibility. This session will feature a special interview with Pete Jenny the Vice President of I/T, Global Operations, and Supply Chain at Cardinal Health, a leading medical device company, sharing their experience in leveraging new technologies to optimize labeling processes. Attendees will hear firsthand how Cardinal Health is adopting innovative solutions to streamline label management, improve approval workflows, and maintain regulatory compliance on a global scale.

December 17, 2024
Adapt, Thrive, and Lead: Insights for Global Medical Device Executives

Key Takeaways from a recent survey of Medical Device Manufacturing Executives. Presented by MedTech Intelligence and Entrada Group, a leading Mexico manufacturing shelter provider, we’ll focus on common challenges global medical device manufacturers are facing. The discussion is based on recent survey data among medical device manufacturing executive respondents. We’ll also explore solutions including what Mexico offers to address the greatest issues, and why the country is a smart, cost-competitive strategy that doesn’t require compromising on quality.

October 29, 2024
The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery

A comprehensive guide to calculating benefit-risk profiles under the EU MDR, focusing on practical strategies and tools to ensure regulatory compliance. Key topics include differentiating between qualitative benefit-risk profiles and quantified benefit-risk ratios, understanding when each is appropriate, and avoiding pitfalls that lead to non-conformances

September 26, 2024
Adopting a RIM Platform in MedTech: Myths vs. Reality

Implementing a Regulatory Information Management (RIM) platform can significantly enhance regulatory processes. However, several misconceptions often prevent medical device companies from adopting these platforms. In this webinar, we'll debunk the most common myths and demonstrate how RIM platforms can quickly generate ROI.

August 27, 2024
Decoding global regulatory pathways: How to classify your Medical Device

Understand how different regions categorize medical devices. Ensure compliance and remain empowered with the knowledge to navigate international regulatory landscapes confidently. Whether you’re targeting the US market with its FDA requirements or aiming for EU approval under the rigorous MDR, we’ll break down the complexities and provide clear, actionable insights.

July 31, 2024
Managing global regulatory strategy and compliance: assessing status, gaps, and needs.

In this webinar, our industry panel of notified bodies, regulatory management & maintenance experts, and medical writers share details of this recent research, explore changing regulatory landscapes, identify the most critical gaps, and offer insights on knowledge, technology and resources to help improve regulatory intelligence and mitigate compliance deficits.

July 18, 2024
Now that the EU MDR deadline is passed, how do you sell your device abroad?

As the EU Medical Device Regulation (MDR) deadline has passed, medical device manufacturers must explore alternative avenues to sell their devices abroad. Leveraging schemes such as MDSAP, Swissmedic, and UKCA in conjunction with ISO 13485, can facilitate market access in various regions. This presentation describes options available to manufacturers who wish to access markets other than the EU.

May 16, 2024
2024 State of the US MedTech Regulation: Innovation, Regulatory Transformation, and Artificial Intelligence

Essenvia unveils its 2024 State of US MedTech Regulation Industry Report that highlights shifts in innovation, AI & digital transformation in MedTech operations, and regulation in the United States medical device industry and provides MedTech executives and regulatory leaders with strategic insights, guidance, and best practices to navigate the shifting landscape in 2024 and beyond.

April 24, 2024 – 10:00 am – 11:00 am
Mastering Compliance: Essential Insights into PMS Documentation

Explore and understand the critical elements of PMS documentation and empower yourselves with effective strategies to navigate its complexities. In this webinar, we will delve into the significance of PMS documentation for medical devices, offering invaluable insights on ensuring compliance with regulatory requirements.

April 23, 2024 – 10:00 am – 11:00 am
High Risk AI under the AI European Act: Must Know Strategies for Medical Device Companies to Achieve Regulatory Excellence

This session is designed to clarify high-risk AI applications within medical devices, helping your team to identify your regulatory responsibilities and plan your strategy effectively. 

April 9, 2024 – 2:00 pm – 3:00 pm
Japan Medical Device Registration & Reimbursement

Japan is the 3rd largest medical device market in the world. However, being successful in Japan requires investigating a number of factors before registration. In this webinar, you'll learn best strategies to register your device in Japan and get device reimbursement.

March 4, 2024
Launch Medical Devices to Market in the EU vs the US

Join us for a discussion on Essential Strategies to navigate the regulatory landscape and ensure you get your device to market on time and with the right tools.

December 5, 2023
Post-EU MDR Compliance: Key Insights and Activities to Maintain Compliance after Device Certification

Join Hilde Viroux, Consulting Director at PA Consulting, and Adam Price, Director or Product, at Rimsys for a discussion about the elements of successful post-EU MDR compliance, including key challenges, post certification requirements and considerations when assessing your organization's preparedness.

September 28, 2023
EU MDR & IVDR Lessons for Regulatory Strategy

The new EU (and forthcoming UK) regulations have underscored the significant relationship between regulatory and revenue. This webinar covers some of the key strategic capabilities including regulatory data management, process automation, and tighter alignment with in-country sponsors and Notified Bodies of high-performing regulatory teams, and outlines steps organizations can take to foster stronger regulatory – revenue alignment.

Upcoming Events & Webinars

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Featured Articles

April 10, 2026

The Healthcare Burnout Backlash (pt 3): How Workflow Redesign Is Helping Healthcare Organizations Offset Staffing Shortages

By Melissa Corneal

As organizations introduce additional technologies, including AI-enabled tools and CRM platforms, these gaps become more pronounced. Those that are seeing meaningful improvements are taking an end-to-end view, evaluating how systems interact within a unified workflow and ensuring that data flows seamlessly and actions are triggered in a coordinated manner, thereby reducing the need for manual intervention and follow-up.

April 3, 2026

The Healthcare Burnout Backlash (pt 2): Positioning AI pilots for success within EHR-integrated environments

By Melissa Corneal

In this part 2 of a 4-part series, Melissa highlight how the moment AI begins to influence decisions or workflows, it is operating within a regulated environment. Aligning with documentation standards, keeping data within established pathways, and ensuring actions are consistently recorded are all ways to support that reality early, rather than adapting to it later. Seen this way, integration is not just a technical milestone.

April 1, 2026

How Rural Health Systems Are Advancing Cardiac Imaging

By Dr. Joseph Cardenas, Dr. Khidir Osman MD, FACC

Geography is effectively determining whether patients receive timely cardiac diagnosis, or even any diagnosis at all. In an effort to address the problem, cardiologists and health systems are increasingly looking to cardiac CT to redefine how advanced imaging can be delivered closer to where patients live.

April 1, 2026
north star

Beyond Reimbursement: Why Market Access is MedTech’s Strategic North Star

By Joan Hinrichs

Companies that embed Market Access early in innovation are the ones best positioned to navigate the changing global landscape.

April 1, 2026

The Human Side of AI Medical Devices: Why Safety Depends on Design, Not Just Algorithms

By Shreya Sridhar

Human factors engineering plays a critical role in the design of AI-enabled medical devices and whether they might improve care or introduce new risks.

March 28, 2026
Healthcare Burnout

The Healthcare Burnout Backlash (pt 1): Burnout Reaches Well Beyond Clinicians

By Melissa Corneal

In this part 1 of a 4-part series, we look at how the burden of digital transformation is impacting the entire healthcare ecosystem, and that while burnout in healthcare is most often framed around clinicians, it does not reflect where the full transformation work is actually being carried...or its impact across healthcare.

March 25, 2026
healthcare data

Clinical Trials Have Too Much Data…That’s the Problem.

By Melissa Mooney

Data has become overwhelming in healthcare. While it has provided tremendous solutions and outcomes, however, it can sometimes be a problem, too! How can data utilization in Clinical Studies and a ground up data strategy help make your technologies, your team, and your trials more efficient?

March 16, 2026
QMS Interoperability

Chicken or the Egg: Should Device Interoperability or QMS Interoperability Come First?

By Carl Washburn

To achieve medical Device Interoperability, system boundaries need to be defined, system architecture needs to be aligned, and interfaces and communication protocols need to be established across individual components of the medical device. In some cases, it is as important to design and implement QMS Interoperability as it is to design Device Interoperability.

View More Combination Products Articles »

TOPICS

  • Digital Health
  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory

Upcoming Events & Webinars

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