Digital weeks are our free to attend MedTech webinar series, designed to bring entire teams
together and provide easy to access essential hot topics. Our digital weeks have 3 sessions a day
and are spread across 3 days making them easy for busy professionals to fit into their working day.
Each session is up to 1 hour which includes time for Q&A.
Testimonial from MedTech Digital Week
“The MedTech Digital Week was, as always, very well organized by Informa. Our session was very well attended, we found the audience really engaged with our session, showing a great deal of interest in the presented content. We look forward to the upcoming events.”
Marina Spasov, Events Manager, ELSEVIER | Research Marketing
DAY 1 – 17 October 2023
Crossing the eSTAR Chasm: How to Transition to FDA’s Mandatory 510(k) eSTAR Submission Process
9:00 AM EDT / 2:00 PM BST / 3:00 PM CEST
This session will educate and prepare medical device manufacturers, regulatory affairs leaders, and regulatory consultants to effectively transition their processes, resources, and operations to seamlessly adopt the eSTAR as the new submission standard. This session will share watchouts, best practices, and tips and tricks to adapt to eSTAR.
Speakers:
Dhriti Roy
VP of Regulatory Affairs Transformation
Essenvia
Soumya Mahapatra
CEO
Essenvia
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Navigating Regulatory Affairs and Ensuring Compliance in a Medtech Scale Up
10:00 AM EDT / 3:00 PM BST / 4:00 PM CEST
- How to enhance your Certification Strategy: Best practices and proven methods
- What you need to implement an effective strategic planning structure to ensure compliance
- Best practices to become certified faster
Speaker:
Ann Vankrunkelsven
RA/QA Manager
Matrix Requirements
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Eudamed: Where Are We Now?
11:00 AM EDT / 4:00 PM BST / 5:00 PM CEST
- Current module release status
- Important tips for manufacturers
- How to use the database
- Compliance deadlines
- Bottlenecks
- Practical solutions
- Roadmap for EUDAMED
Speaker:
Richard Houlihan
CEO
EirMed
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DAY 2 – 18 October 2023
How is IVDR Impacting Precision Medicine Clinical Trials Today?
10:00 AM EDT / 3:00 PM BST / 4:00 PM CEST
The IVDR provides a robust regulatory framework for IVDs, intending to improve patient safety and market access. However, implementation of the regulation has identified several challenges, particularly for performance studies and drug clinical trials involving IVDs. This webinar will provide an overview of the IVDR and IVD clinical performance studies and discuss where the regulation may impact trials of medicinal products, to help Sponsors and manufacturers prepare for their upcoming clinical trials in the EU. Audience members will be provided with an overview of:
- IVDR implementation, key definitions and timelines
- Basic requirements for IVD performance studies
- Using CE marked devices in performance studies and clinical trials
- Annex XIV – IVD performance study application requirements
- The In-house exemption (article 5(5))
Speakers:
James Lappin
Head, Clinical Compliance and Quality Assurance • Senior Leadership Team (QA &.; RA)
ARC Regulatory Limited
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Notified Body Experience with Clinical Expert Consultation Panels
11:00 AM EDT / 4:00 PM BST / 5:00 PM CEST
The presentation will help clarify the steps involved in the administrative process and the review process with the expert panels. The experience NBs have had with the expert panels will be elaborated. The presentation of the opinions by the expert panels and their interpretation by NBs will be discussed. Some steps that are being proposed to improve this process will also be presented. This will, in turn, help you understand the NB’s role in this expert panel process and better anticipate the timelines for the completion of your project.
Speakers:
Annapoorna Rajan
Project Manager
DEKRA Product Testing & Certification
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