Celegence
Celegence
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Celegence Expertise Interview: Joy Greidanus, Director and Medical Device SME
Discover how Celegence supports the medical and diagnostic industry in the US with comprehensive regulatory services and solutions. In this insightful interview, Joy Greidanus, Director and Medical Device SME, discusses Celegence's strategies for helping companies navigate the complex regulatory landscape in the United States.
📌 Watch now to learn about Celegence's services and solutions:
1. Regulatory strategy consulting for FDA compliance
2. Expertise in FDA guidance interpretation and interactions
3. Comprehensive support for medical device and diagnostic submissions
4. Post-market surveillance and reporting
5. Clinical trial and study management
6. Customized consulting for overcoming regulatory challenges
About the Speaker:
Joy Greidanus, with her extensive expertise in the medical device industry, shares valuable insights into the unique challenges and solutions for regulatory compliance in the US market.
Stay connected with Celegence for more expert insights:
Website: www.celegence.com/
LinkedIn: www.linkedin.com/company/celegence/
Переглядів: 310

Відео

Celegence Expertise Interview: Joseph Richardson Larbi, Director and Medical Device SME
Переглядів 30Місяць тому
Delve into Celegence's specialized medical device services and solutions tailored for the EU market. In this exclusive interview, Joseph Richardson Larbi, Director and Medical Device SME, provides insights into how Celegence supports medical device companies in navigating the complex EU regulatory landscape. 📌 Watch now to learn about Celegence's services and solutions: 1. Comprehensive regulat...
Celegence Expertise Interview: Insights from Lakshmeenarayana Goundalkar, Chief Delivery Officer
Переглядів 67Місяць тому
Explore how Celegence supports pharmaceutical and medical device organizations with AI-enabled regulatory services and solutions. In this exclusive interview, Lakshmeenarayana Goundalkar, Chief Delivery Officer of Regulatory Services, discusses the innovative strategies and technologies that drive regulatory compliance and efficiency. 📌 Watch now to learn about Celegence's services and solution...
AI-Powered MDR Maintenance: The Future State of Regulatory Compliance
Переглядів 1062 місяці тому
Facing regulatory challenges in the healthcare industry? Discover how Celegence's AI-enabled technology and expert consulting services can streamline your regulatory compliance process, saving time and reducing costs for pharmaceutical, medical device, and IVD clients globally. With pressures mounting from increased regulatory requirements, how are regulatory leaders managing? Join Shruti as sh...
Efficient collaboration in PMS document reviews - CAPTIS™ Software for EU MDR and IVDR Compliance
Переглядів 1599 місяців тому
Are your literature documents suffering from lengthy turnover times due to endless iterations from multiple reviewers? Make team collaboration super-efficient with CAPTIS™ In today’s fast-paced world, coordinating with multiple reviewers on the same document can be a major challenge. With CAPTIS, multiple reviewers can seamlessly collaborate on the same document simultaneously. Individual secti...
Standard Templates for PMS Documentation in CAPTIS™ - Software for EU MDR and IVDR Compliance
Переглядів 13010 місяців тому
Struggling to create standardized templates and regulatory guidance to help create your product’s documentation? Structure your regulatory templates with ease using ‘Template Configurations’ in CAPTIS™! It’s now super easy for your team to create standard documentation for their medical, IVD, or pharma products. Configure templates with built-in boilerplate and example text that can be used as ...
Automated report writing with CAPTIS™ Data Dictionary - Software for EU MDR and IVDR Compliance
Переглядів 8810 місяців тому
Do you find yourself in a manual ‘Search, Copy, Paste and Verify’ loop when producing PMS Reports and Documentation? A single change within your master data may fill you with dread and lead to inconsistencies across documents! 🎯 Revolutionize report writing and maintenance with the ‘Data Dictionary’ in CAPTIS™ Medical Writers can save any piece of information that needs to be repeated throughou...
Is the EU MDR Extension a Blessing or a Curse? - Webinar
Переглядів 23110 місяців тому
This webinar will help you to better understand the effects of the EU MDR extension on manufacturers, and notified bodies, how to deal with it and what medical device manufacturers must do to stay compliant. The extension of the EU MDR deadlines from the EU Commission was received positively by the medical device industry. The extension will impact manufacturers’ preparedness towards clinical d...
CAPTIS™ Copilot - Most Advanced AI Compliance Solution for the Life Sciences Industry
Переглядів 14411 місяців тому
Are you losing valuable time when manually searching and extracting critical data elements from within your scientific papers? Access extracted data drafts instantaneously through #AI with CAPTIS™ Copilot. With built-in artificial intelligence, CAPTIS automates highly manual extraction tasks for medical writers, such as summarizing the sample study size or performance outcomes and provides you ...
Automatic Content Linking in PMS Documentation with CAPTIS™ - Software for EU MDR & IVDR Compliance
Переглядів 4911 місяців тому
Do you spend too much time reviewing PMS documentation, trying to verify report contents? Need to sort through multiple files to find the referenced source? Say goodbye to time-consuming content verification with CAPTIS™! Using a revolutionary feature called ‘Content Linking’, authors can easily maintain traceability when writing a report. CAPTIS automatically generates links to the original in...
CAPTIS™ - Software Solution for Dynamic Literature Tables
Переглядів 8811 місяців тому
Are your Literature Review Table updates time-consuming and prone to human error? Get dynamic and wave goodbye to risky manual updates! CAPTIS™ is the software solution for dynamic literature tables. By automatically capturing changes in search strategy and included articles, CAPTIS seamlessly updates your PMS reports - from PRISMA diagrams to Appendices, allowing you to focus on your literatur...
Easy Reference Management with CAPTIS™ - Software for EU MDR and IVDR Compliance
Переглядів 49Рік тому
Have you ever had to manually add and track references in your PMS documents? Are you losing time manually numbering and rearranging a bibliography? Get it right the first time with ‘Easy Reference Management’ in CAPTIS™! CAPTIS’s built-in, validated reference manager automatically builds and numbers a library from appraised articles, staying in sync with new or removed citations and allowing q...
Automated Abbreviation Management with CAPTIS™ - Software for EU MDR and IVDR Compliance
Переглядів 48Рік тому
Are you a Medical Writer struggling to keep track of the countless abbreviations, worrying that your document has an inaccurate list? Welcome to ‘Automated Abbreviation Management’ in CAPTIS™! You no longer need to sift through your document to compile and list abbreviations manually. CAPTIS does it automatically without you lifting a finger! And if you need to know an abbreviation’s full form,...
IVDR Survival Guide-Common Pitfalls Encountered in Complying with Regulation’s Requirements: Webinar
Переглядів 249Рік тому
Celegence has the expertise to provide support for all of your In Vitro Diagnostic (IVD) regulatory needs; from strategic consulting, registration, device classification, PERs, to in country representation. We have the wealth of knowledge to help you navigate through the complex challenges that IVD Regulation inherently brings. To know more: www.celegence.com/services/ivdr/ Webinar Background T...
Webinar - Clinical Evaluation of Dental Medical Devices - Lessons Learned from NB Assessments
Переглядів 163Рік тому
Celegence (www.celegence.com/services/medical-device-services/) provides the medical device industry with consulting services that are tailored to the evolving needs of manufacturers. Our suite of services including EU MDR related support allows you to focus on your core responsibilities. With our guidance, bringing your devices to the market and keeping them there will be easier for your regul...
Dossplorer™ - Advanced Cloud-based Dossier Management Solution
Переглядів 177Рік тому
Dossplorer™ - Advanced Cloud-based Dossier Management Solution
Life Sciences Regulatory Solutions and Services - Overview of Celegence
Переглядів 330Рік тому
Life Sciences Regulatory Solutions and Services - Overview of Celegence
CAPTIS™ - Technology for EU MDR & IVDR Compliance
Переглядів 238Рік тому
CAPTIS™ - Technology for EU MDR & IVDR Compliance
Analysis of EU MDR & IVDR Amendment Proposal 2023/0005 - Celegence
Переглядів 189Рік тому
Analysis of EU MDR & IVDR Amendment Proposal 2023/0005 - Celegence
Implications for Medtech Companies with FDA Rollout of the New QMSR to Replace Current QSR - Webinar
Переглядів 142Рік тому
Implications for Medtech Companies with FDA Rollout of the New QMSR to Replace Current QSR - Webinar
Unlocking The Value Of Regulatory Dossiers With eCTD Viewing Technology - Dossplorer™ Webinar
Переглядів 138Рік тому
Unlocking The Value Of Regulatory Dossiers With eCTD Viewing Technology - Dossplorer™ Webinar
Navigating the In Vitro Diagnostic Regulation (IVDR) Rollout for Legacy & New Devices - Webinar
Переглядів 142Рік тому
Navigating the In Vitro Diagnostic Regulation (IVDR) Rollout for Legacy & New Devices - Webinar
Video Testimonial From Jim Talbot - Zap Surgical
Переглядів 17Рік тому
Video Testimonial From Jim Talbot - Zap Surgical
How to Optimize the ROI on Your RIMS Solution - Webinar
Переглядів 43Рік тому
How to Optimize the ROI on Your RIMS Solution - Webinar
Webinar - Process & Technology Innovation in EU MDR Compliance
Переглядів 57Рік тому
Webinar - Process & Technology Innovation in EU MDR Compliance
Navigating eCTD Submissions in China - Webinar
Переглядів 164Рік тому
Navigating eCTD Submissions in China - Webinar
Taking Advantage of the EU MDR Delay in Uncertain Times - Celegence Webinar
Переглядів 48Рік тому
Taking Advantage of the EU MDR Delay in Uncertain Times - Celegence Webinar
Celegence EUMDR Webinar - How To Start Preparing Your RA QA Team For The EUDAMED Database
Переглядів 127Рік тому
Celegence EUMDR Webinar - How To Start Preparing Your RA QA Team For The EUDAMED Database
Clinical Evaluations for Unique Product Types Under the EU MDR - Webinar
Переглядів 102Рік тому
Clinical Evaluations for Unique Product Types Under the EU MDR - Webinar
Best Practices for UDI Implementation and EUDAMED Submissions - Webinar
Переглядів 685Рік тому
Best Practices for UDI Implementation and EUDAMED Submissions - Webinar

КОМЕНТАРІ

  • @MTB_Rider_96
    @MTB_Rider_96 6 місяців тому

    can a product made up of two 510k cleared medical devices and no biologics or drugs be classified as a combination device?

  • @exploreyourdreamlife
    @exploreyourdreamlife 9 місяців тому

    Your explanation of the effects of EU MDR extension are truly effective. Thanks for being such a great teacher! Liked and Subbed!