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.

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.

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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.

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.

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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.

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.

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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

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

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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.

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.

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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.

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.

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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.

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.

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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.

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.

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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.

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.

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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.

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.

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