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Digital Health


Upcoming Events & Webinars

- Open for Registration.
- Complimentary

More events coming soon!

On Demand Webinars

February 26, 2025 – 2:00 pm – 3:00 pm
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 – 11:00 am – 12:00 pm
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 – 2:00 pm – 3:00 pm
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 – 10:00 am – 11:00 am
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 – 1:00 pm – 2:00 pm
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 – 10:00 am – 11:00 am
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 – 12:00 pm – July 31, 2024 – 1:00 pm
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 – 2:00 pm – 3:00 pm
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 – 12:00 pm – 1:00 pm
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.





Learning Center

  • HD PLM Webinar – Smarter Decisions, Better Products for Orthopedic and Medical Device Development
  • Integrated Quality with PLM
  • Manage Requirements and Traceability with a Unified PLM System
  • How to Eliminate the Biggest Time Wasters for Engineers: An Energist Success Story
  • Future Test - A Case Study
  • Bausch+Stroebel - A Case Study
  • Medical Device Development Brochure
  • Compliance Management for Medical Devices
  • Designing Medical Devices to Improve Patient Outcomes: An AMR Report

More Resources

  • Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions
  • Pharmaceutical and Medical Device Sector Guidance for Product Life Cycle Accounting

Featured Articles

November 27, 2024
sustainable design

From design to disposal: Reducing the footprint of single-use drug delivery devices

By Alex Fong

How can drug delivery devices manage competing priorities - reducing overall carbon footprint without expense to patient and practitioner safety or treatment efficacy. Sustainability strategies must account for commercial and budgetary pressures.

July 8, 2024
LDT Development

The FDA’s final lab developed test rule places new burdens on manufacturers

By Laura Housman

Diagnostic manufacturers and pharmaceutical sponsors with therapeutics that rely on biomarker identification or companion diagnostics should adjust their commercialization and partnership strategies to fit the new regulatory environment.

January 22, 2023
Rama Chellappa

Instilling Trust in AI

Rama Chellappa, PhD, John Hopkins University Bloomberg Distinguished Professor in electrical, computer, and biomedical engineering, and co-author of "Can We Trust AI?" looks at the promise of AI in health care and how we can best utilize this extraordinary tool to save lives and improve health equity.

October 12, 2020
Arlen Ward, System Insight Engineering

Computer Modeling and Simulation Helps MedTech Developers Bring Innovation to Reality

By Maria Fontanazza

No longer just “the big company advantage,” Arlen Ward discusses how CM&S is an accepted and viable device industry path to market for large and small medical device makers alike.

September 2, 2020
Checkbox

Cybersecurity, COVID-19 and EU MDR Hot Topics of the 2020 MedTech Summer

By MedTech Intelligence Staff

Although the full impact of COVID-19 is uncertain, one sure thing is that industry continues to crave information to help them navigate EU MDR.

June 15, 2020
Abbott FreeStyle Libre 2

FDA Clears Abbott’s Continuous Glucose Monitoring System for Use in Children

By MedTech Intelligence Staff

The FreeStyle Libre 2 now has indications for children ages four and older.

May 25, 2020
FDA

In Face of COVID-19, FDA Updates Adverse Event Reporting Guidance Document

By MedTech Intelligence Staff

The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.

March 17, 2020
N95 respiratory mask

Amidst COVID-19 Pandemic, Scams Involving Personal Protective Equipment Emerge

By MedTech Intelligence Staff

As the saying goes, if it looks too good to be true, it probably is.

View More Combination Products Articles »

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

Upcoming Events & Webinars

No posts found.



On Demand Events & Webinars

February 26, 2025 – 2:00 pm – 3:00 pm
Are you talking to me? Communicating effectively with your Notified Body for an Accountable and Sustainable Working Relationship
January 21, 2025 – 11:00 am – 12:00 pm
Medical Device Labeling Best Practice for 2025: The Global Design Master
December 17, 2024 – 2:00 pm – 3:00 pm
Adapt, Thrive, and Lead: Insights for Global Medical Device Executives
October 29, 2024 – 10:00 am – 11:00 am
The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery

Combination Products

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