Watch Now: Getting MDR Clinical Evaluations Right – Practical Guidance for Dental Device Manufacturers

With the transition from MDD to MDR, dental device manufacturers are facing increased scrutiny around clinical evidence, documentation gaps, and evaluation methodology. Aligning with EU MDR requirements can be especially challenging given the wide variety of dental products and risk classifications.

In this expert-led on-demand webinar, our speakers provide targeted guidance on building MDR-compliant Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and supporting documentation tailored to dental devices.
If you’re looking to improve your clinical evaluation strategy and minimize the risk of delays or rejections by Notified Bodies – this session is for you.

AI in Action: Tech-Empowerment in Medical and Technical Writing

Watch Now: AI in Action – Tech-Empowerment in Medical and Technical Writing

Artificial Intelligence (AI) is already reshaping the way regulatory submissions are created, reviewed, and delivered across life sciences. This webinar, hosted in partnership with RAPS, explores how AI is actively transforming medical and technical writing for pharmaceutical and medical device companies.

From live tool demonstrations to real-world case studies, you’ll gain first-hand knowledge on how leading organizations are implementing AI to increase efficiency, reduce manual workloads, and elevate submission quality.

Don’t miss this opportunity to understand what practical AI adoption looks like today—and how your team can start leveraging it for measurable compliance and operational gains.

Watch Now: Staying Compliant: Strategies for EU MDR and Beyond

Staying compliant with the EU Medical Device Regulation (MDR) is no longer just a checkbox exercise. As regulatory demands grow in complexity, medical device manufacturers must rethink their approach to compliance—prioritizing strategy, accuracy, and adaptability.

In this on-demand webinar, regulatory experts from Celegence provide a deep dive into the most pressing MDR challenges and how leading organizations are leveraging tools, processes, and expert insights to minimize risks and maintain certification with confidence.

Watch Now: The Regulatory Landscape in 2025 – What You Need to Know

Pharmaceutical companies today are navigating an increasingly dynamic and complex regulatory environment. As we move through 2025, staying informed about regulatory changes and preparing for what lies ahead is essential for maintaining compliance and accelerating market access.

In this exclusive on-demand webinar, our experts explore key regulatory trends, submission challenges, and global authority expectations that will define the pharmaceutical regulatory landscape. Don’t miss this opportunity to gain strategic insights and practical knowledge from seasoned regulatory affairs experts.

Watch Now: Simplify Systematic Literature Reviews in Regulatory Compliance Using AI

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Simplify Systematic Literature Reviews in Regulatory Compliance Using AI

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Systematic Literature Reviews (SLRs) are essential for regulatory compliance in medical device submissions, yet they present challenges such as data complexity, evolving regulatory expectations, and resource-intensive processes. Traditional methods often lead to delays, inconsistencies, and compliance risks—but AI-powered automation can transform the way literature reviews are conducted.

In this exclusive on-demand webinar, our experts explore how automation and AI can streamline SLR workflows, enhance data accuracy, and ensure compliance with regulatory bodies like the FDA and EMA.

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Watch the webinar now and gain actionable insights into SLR automation and compliance

Explore More on Systematic Literature Reviews & Compliance

Streamline Clinical Evaluation Report Compliance – Learn best practices for ensuring compliance with evolving CER requirements and regulatory expectations.

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Are you seeking assistance with a regulatory compliance need?

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Please complete the form below to outline your medical device/pharmaceutical/IVD regulatory support requirements. Our team will promptly review your submission and reach out to confirm a consultation time. Thank you for your interest.

Watch Now: Webinar – Overcoming Regulatory Challenges for Cell & Gene Therapy Products

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Overcoming Regulatory Challenges for Cell & Gene Therapy Products

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Bringing an Advanced Therapy Medicinal Product (ATMP) to market is a complex process, requiring a deep understanding of regulatory requirements, scientific rigor, and compliance excellence. With increasing scrutiny from regulatory authorities such as the FDA and EMA, pharmaceutical companies must proactively address compliance challenges for cell-based therapies, gene therapies, and combined ATMPs.

In this exclusive on-demand webinar, our experts explore strategic approaches to overcoming ATMP regulatory hurdles, ensuring compliance, and streamlining approvals in global markets.

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Don’t miss this opportunity to enhance your regulatory skills and understanding.

Explore More on ATMP Regulatory Challenges

📖 ATMP Regulation in the EU and US: Global Convergence? – Learn about the regulatory alignment efforts between the FDA & EMA and what this means for ATMP manufacturers.

[/fusion_li_item][fusion_li_item icon=”fa-address-book fas” iconcolor=”” hue=”” saturation=”” lightness=”” alpha=”” circlecolor=””]

📖 Navigating the Complex CMC Landscape of ATMPs and CGTs – Understand the key challenges and strategies for Chemistry, Manufacturing, and Controls (CMC) in ATMP and CGT development.

Are you seeking assistance with a regulatory compliance need?

Watch Now – AI and Automation for Regulatory Compliance in Medical Devices Smarter Data Management Webinar

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AI and Automation for Regulatory Compliance in Medical Devices – Smarter Data Management

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In today’s stringent regulatory environment, medical device and IVD manufacturers face mounting challenges to remain compliant while managing growing data complexities. Discover how AI and automation, including Celegence’s CAPTIS® platform, can streamline regulatory processes, improve data accuracy, and reduce compliance costs.

This on-demand webinar provides an in-depth overview of technology-driven solutions to help regulatory professionals modernize their compliance efforts. As regulatory demands evolve, smarter solutions like CAPTIS® are essential for managing compliance effectively.

The session demonstrates how AI-powered tools and automation technologies can simplify regulatory data management, optimize submission quality, and ensure compliance with EU MDR and IVDR requirements. By leveraging AI-driven solutions, regulatory teams can significantly ease their burden, improve efficiency, and drive precision in clinical and technical documentation processes.

With real-world insights and practical examples, this webinar equips you with actionable strategies to simplify regulatory affairs, enhance accuracy, and achieve cost-effective compliance management.

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Don’t miss this opportunity to enhance your regulatory skills and understanding.

Please complete form aside to outline your medical device regulatory support requirements. Our team will promptly review your submission and reach out to confirm a consultation time. Thank you for your inter

Watch Now – Lean Authoring for Regulatory Submissions

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animation_direction=”left” animation_color=”” animation_speed=”0.1″ animation_delay=”0″ animation_offset=”” last=”true” border_position=”all” first=”true”][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”center” size=”2″ animated_font_size=”” fusion_font_family_title_font=”Poppins” fusion_font_variant_title_font=”500″ font_size=”35px” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Transform Regulatory Submissions with Lean Authoring: Faster, Smarter, Better[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”center” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”18px” line_height=”” letter_spacing=”” text_transform=”” text_color=”#152549″ animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Join us for an insightful discussion where regulatory experts unveil how Lean Authoring is revolutionizing submission processes for pharmaceutical and medical device industries.

This webinar explores actionable strategies for creating optimized, compliant submissions, with a focus on structuring data for faster regulatory approvals and streamlined workflows.

Through real-world case studies, our speakers illustrate how Lean Authoring reduces document duplication, improves submission accuracy, and ensures faster decision-making—empowering your team to stay ahead of regulatory requirements.

Whether you’re responsible for regulatory submissions, data governance, or compliance management, this session will equip you with the knowledge to implement Lean Authoring effectively and achieve measurable results.

Don’t miss this opportunity to enhance your submission efficiency and align with global Health Authority standards.[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”center” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”18px” line_height=”” letter_spacing=”” text_transform=”” text_color=”#152549″ animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

Don’t miss this opportunity to enhance your regulatory skills and understanding.

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Gain actionable knowledge and insights with our webinar:

[/fusion_text][fusion_checklist type=”icons” icon=”” iconcolor=”var(–awb-custom13)” hue=”” saturation=”” lightness=”” alpha=”” circle=”no” circlecolor=”rgba(110,203,213,0)” textcolor=”” size=”” item_padding_top=”” item_padding_right=”” item_padding_bottom=”” item_padding_left=”” divider=”” divider_color=”” odd_row_bgcolor=”” even_row_bgcolor=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” parent_dynamic_content=””][fusion_li_item icon=”” iconcolor=”” hue=”” saturation=”” lightness=”” alpha=”” circlecolor=””]Streamlined Workflows: Learn how Lean Authoring accelerates submission processes by organizing data for improved efficiency and reduced turnaround times.[/fusion_li_item][fusion_li_item icon=”” iconcolor=”” hue=”” saturation=”” lightness=”” alpha=”” circlecolor=””]Document Reusability: Explore strategies to enhance document reuse across multiple submissions, cutting down on duplication and manual effort.[/fusion_li_item][fusion_li_item icon=”” iconcolor=”” hue=”” saturation=”” lightness=”” alpha=”” circlecolor=””]Regulatory Compliance Simplified: Gain insights into creating submissions that meet evolving Health Authority standards while minimizing non-compliance risks.[/fusion_li_item][fusion_li_item icon=”” iconcolor=”” hue=”” saturation=”” lightness=”” alpha=”” circlecolor=””]Resource Optimization: See how Lean Authoring helps teams save time and resources by focusing on critical submission components.[/fusion_li_item][fusion_li_item icon=”” iconcolor=”” hue=”” saturation=”” lightness=”” alpha=”” circlecolor=””]Actionable Best Practices: Discover practical methods to implement Lean Authoring in your organization for measurable results and streamlined regulatory operations.[/fusion_li_item][/fusion_checklist][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container admin_label=”Contact” type=”legacy” 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Are you seeking assistance with a regulatory compliance need?

Watch Our Webinar – The Art of Benefit-Risk Calculation – Essential Tools for EU MDR Mastery

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The Art of Benefit-Risk Calculation – Essential Tools for EU MDR Mastery

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”center” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”18px” line_height=”” letter_spacing=”” text_transform=”” text_color=”#152549″ animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

Join us for an engaging discussion where medical device regulatory subject matter experts will explore tools and strategies to streamline benefit-risk calculations under the EU MDR framework.

This webinar will provide practical guidance on calculating both qualitative and quantitative benefit-risk profiles, helping you avoid non-conformances and deliver compliant, data-driven submissions.

Through real-world case studies, our experts will demonstrate how to streamline the assessment process and present measurable outcomes that stand up to regulatory scrutiny. Whether you’re involved in regulatory submissions or product development, this session will give you the tools you need to navigate the EU MDR’s rigorous benefit-risk requirements.

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Don’t miss this opportunity to enhance your regulatory skills and understanding.

[/fusion_text][fusion_youtube id=”https://youtu.be/OvPUgtxbXDo” alignment=”center” width=”1200px” height=”” start_time=”” end_time=”” autoplay=”true” mute=”false” loop=”false” controls=”true” api_params=”&rel=0″ title_attribute=”The Art of Benefit-Risk Calculation – Essential Tools for EU MDR Mastery – Webinar” video_facade=”” thumbnail_size=”auto” margin_top=”” margin_bottom=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” css_id=”” structured_data=”off” video_upload_date=”” video_duration=”” video_title=”” video_desc=”” /][/fusion_builder_column][fusion_builder_column type=”1_2″ layout=”1_2″ last=”false” spacing=”yes” center_content=”no” hide_on_mobile=”no” background_color=”” background_image=”” background_repeat=”no-repeat” background_position=”left top” hover_type=”none” link=”” border_position=”all” border_color=”” border_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”” animation_speed=”0.1″ animation_offset=”” class=”” id=”” min_height=”” first=”true” border_sizes_top=”0px” border_sizes_bottom=”0px” border_sizes_left=”0px” border_sizes_right=”0px” spacing_right=”2%”][fusion_separator style_type=”none” hide_on_mobile=”medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” flex_grow=”0″ top_margin=”20px” bottom_margin=”” width=”” alignment=”center” border_size=”” sep_color=”rgba(255,252,252,0)” icon=”” icon_size=”” icon_color=”” icon_circle=”” icon_circle_color=”” /][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

Gain actionable knowledge and insights with our webinar:

Understand the Benefit-Risk Framework: Explore how the EU MDR defines and evaluates benefit-risk balance.

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Real-World Case Studies: Learn from industry case studies to understand common pitfalls and best practices for compliance.

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Prevent Non-Conformances: Avoid major non-conformances in benefit-risk documentation through effective strategies.

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Qualitative vs. Quantitative Assessments: Determine when to use qualitative versus quantitative assessments and how to present both effectively.

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Streamline Benefit-Risk Calculations: Apply tools and techniques that simplify the process of quantifying benefit-risk data for regulatory approval.

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Ensure Compliance with Notified Bodies: Discover how to meet the expectations of Notified Bodies for faster regulatory approval.

Are you seeking assistance with a regulatory compliance need?

Watch Our Webinar – Managing Global Regulatory Strategy and Compliance: Insights from the 2024 Survey

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Managing Global Regulatory Strategy and Compliance: Assessing Status, Gaps, and Needs

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Join us for an engaging discussion where industry leaders will share key insights and findings from a recent survey conducted with Medtech Intelligence. This webinar will explore the top challenges and opportunities in the medical device industry, discuss planned investments for the near and long term, and provide guidance on aligning with evolving regulatory requirements. Topics will include identifying regulatory gaps, risk mitigation strategies, and leveraging technology and resources to enhance compliance.

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Don’t miss this opportunity to enhance your regulatory skills and understanding.

Gain actionable knowledge and insights with our webinar:

Identify Regulatory Gaps: Understand why gaps in regulatory intelligence and compliance processes are overwhelming for teams and organizations.

[/fusion_li_item][fusion_li_item icon=”” iconcolor=”” hue=”” saturation=”” lightness=”” alpha=”” circlecolor=””]

Risk Mitigation: Learn strategies to mitigate risks associated with the growing complexities of global regulatory compliance.

[/fusion_li_item][fusion_li_item icon=”” iconcolor=”” hue=”” saturation=”” lightness=”” alpha=”” circlecolor=””]

Focus Areas: Discover where to prioritize MDR/IVDR efforts and investments.

[/fusion_li_item][fusion_li_item icon=”” iconcolor=”” hue=”” saturation=”” lightness=”” alpha=”” circlecolor=””]Technology and Resources: Explore technologies and resources for cost-effective management of current bandwidth limitations in the industry.[/fusion_li_item][/fusion_checklist][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container admin_label=”Contact” type=”legacy” hundred_percent=”no” hundred_percent_height=”no” min_height_medium=”” min_height_small=”” min_height=”” hundred_percent_height_scroll=”no” align_content=”stretch” flex_align_items=”flex-start” flex_justify_content=”flex-start” flex_column_spacing=”” hundred_percent_height_center_content=”yes” equal_height_columns=”no” container_tag=”div” menu_anchor=”demoCTA” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” margin_top_medium=”” margin_bottom_medium=”” margin_top_small=”” margin_bottom_small=”” 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Are you seeking assistance with a regulatory compliance need?