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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

No posts found.





Featured Articles

January 20, 2026
Off-label and contraindicated medical device use

The Risk of Using a Device Off-Label Versus Contraindicated

By Attly Aycock

While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.

January 20, 2026
Balancing Cyber Risk

The FDA Raised the Bar on MedTech Cybersecurity: Are Companies Ready?

By Justin Kozak

In the current Cyber Threat environment, companies must have strong cyber liability insurance. Policies must specifically account for cyber-physical risks and the substantial costs of post-market remediation, including mandatory software patches and patient notifications. Insurers are well aware of the 524B mandate and are increasingly requiring proof of compliance before issuing coverage or offering favorable rates. How do you assure your cyber risk plan insurable?

January 20, 2026
ChatGPT

How ChatGPT Health is rewriting patient engagement

By Christoph Lippuner

A recent survey of 2,000 UK patients found one in four patients (24%) already use AI for health guidance, and nearly one in three (30%) would be willing to consult AI or social media rather than wait to see a clinician. Despite this growing reliance on digital tools, the same survey revealed a disconnect in patient confidence, with almost 80% reporting that they do not feel fully in control of their healthcare. How might ChatGPT Health accelerate this shift, as well as what needs to happen to ensure AI adoption genuinely empowers patients rather than adding further complexity?

January 15, 2026
Domico Med-Device in Mexico

Contract Manufacturer, Domico Med-Device, opens 23,000 sq ft Facility in Mexico

omico’s new facility expands its global production capacity and enhances its ability to be close to customers without taking on excessive risk.

January 6, 2026
Medical Device R&D Bottleneck

R&D Operations Bottlenecks in Large Life Sciences Organizations: What can MedTech Leaders Do?

By Venkatesan (Venkat) Muthukrishnan

How is software-enablement — connected devices and artificial intelligence — reshaping how products are conceived, developed, and deployed in clinical practice? Fragmented operations in large MedTech organizations are not keeping pace with the complexity of products in their pipelines.

January 6, 2026
Superemployees - AI human evolution

How is AI Enabling Darwinian growth for Life Science Professionals?

By Ivor Campbell

The initial fear that the artificial intelligence and machine learning evolution will replace humans is shifting. A new narrative recognizes the potential for an AI-enabled workforce — one where the technology is a jobs creator, enabling us all to be more productive rather than making millions of people redundant or obsolete — actually giving rise to the multi-disciplinary, power employee.

December 4, 2025

The Hidden Complexities of Medical Needle Design

By Kelly Peterson

Whether gluing or molding, designers must carefully address each challenge to ensure reliable, consistent, and accurate manufacturing – and to avoid costly redesigns or patient safety risks later.

December 4, 2025
Smart Critical Care

Using AI and LLMs to fill in fragmented data gaps within complex critical care

By Dimitar Baronov, PhD

AI and large language models (LLMs) are revolutionizing critical care by integrating scattered data from various sources to deliver real-time insights. This allows for prompt escalation or de-escalation of treatment and enhances patient outcomes. These technologies also help reduce staffing issues and prevent clinician burnout by continuously monitoring patient risk and supporting decision-making in busy ICU settings.

View More Combination Products Articles »

TOPICS

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

Upcoming Events & Webinars

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