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Masterclass: The regulation of SaMD in Europe
Are you trying to get your SaMD product regulated in Europe? Keep reading, this masterclass is for you!
Regulation is an absolute essential for digital health companies who want to be accepted into clinical and payer groups. What are the must know and do’s and don’ts when attempting to take your SaMD product through regulatory pathways in Europe? Join us in this Masterclass led by S3 Connected Health to learn more about:
- Overview of current regulations that govern the SaMD products in Europe & General requirements from regulatory bodies
- The evolution of Europe regulatory regimes for SaMD & Current classification: EU Medical Device Regulation (MDR) vs. the old Medical Device Directive (MDD) & Local Considerations (non-EU countries like the UK).
- Recommended approach when engaging with European regulators: who to talk to, timelines constraints, etc.
- Changes expected in the European regulatory regimes for SaMD in the next few years
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Masterclass: The regulation of SaMD in Europe
Join this HealthXL Event today:
Participate in this Digital Health Sprint in order to:
- Deep dive into a topic over 2 focused sessions.
- Engage with a small group of 10 global thought-leaders throughout.
- This sprint is outcome-focused: HealthXL and participants create exclusive outputs.
- Grow your network with our break out sessions.
You actively participate in this discussion. Spaces are limited to 8 - 12 people, allowing you to focus on quality in-depth conversations.
Don't miss your opportunity to connect with senior leaders to shape the future of digital health. Because only if you are prepared now can you lead the future.
Are you trying to get your SaMD product regulated in Europe? Keep reading, this masterclass is for you!
Regulation is an absolute essential for digital health companies who want to be accepted into clinical and payer groups. What are the must know and do’s and don’ts when attempting to take your SaMD product through regulatory pathways in Europe? Join us in this Masterclass led by S3 Connected Health to learn more about:
- Overview of current regulations that govern the SaMD products in Europe & General requirements from regulatory bodies
- The evolution of Europe regulatory regimes for SaMD & Current classification: EU Medical Device Regulation (MDR) vs. the old Medical Device Directive (MDD) & Local Considerations (non-EU countries like the UK).
- Recommended approach when engaging with European regulators: who to talk to, timelines constraints, etc.
- Changes expected in the European regulatory regimes for SaMD in the next few years
Participants
Participants
Jim O'Donoghue
President , S3 Connected Health
Padraig Maguire
Head of Quality & Regulatory Affairs at S3 Connected Health
Karine Soulat
Consultant, Wellthy Therapeutics
Tim Ruckh
Digital Health Clinical Data Collection Lead at AstraZeneca
Hicham Naim
Takeda
Ivan Jurisic
Founder/Business Consultant, Patients Influence
Jordi Lopez Almendros
Digital Business Partner, Chiesi
Brian Binkowski
Director of Quality, Twill
Rob Milnes
CEO, Fertility Focus
Aisling Murray
Sr. Director, Commercial Development, BrightInsight
Hans Middelhoven
Global VBHC leader, Roche
Up to 12
Masterclass: The regulation of SaMD in Europe
Are you trying to get your SaMD product regulated in Europe? Keep reading, this masterclass is for you!
Regulation is an absolute essential for digital health companies who want to be accepted into clinical and payer groups. What are the must know and do’s and don’ts when attempting to take your SaMD product through regulatory pathways in Europe? Join us in this Masterclass led by S3 Connected Health to learn more about:
- Overview of current regulations that govern the SaMD products in Europe & General requirements from regulatory bodies
- The evolution of Europe regulatory regimes for SaMD & Current classification: EU Medical Device Regulation (MDR) vs. the old Medical Device Directive (MDD) & Local Considerations (non-EU countries like the UK).
- Recommended approach when engaging with European regulators: who to talk to, timelines constraints, etc.
- Changes expected in the European regulatory regimes for SaMD in the next few years
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Join a community of gamechangers in digital health. With a HealthXL membership, you meet like-minded people with unique perspectives. And as a HealthXL member, you get access to regular Digital Health Meetings.
Stay informed on the HealthXL Communities Hub. Connect with your peers, receive notifications about the latest interactive Meetings, get curated digital health news and access industry reports, insights, shared resources and more.
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Frequently Asked Questions
What is a HealthXL Digital Health Meeting?
HealthXL Digital Health Meetings are private group meetings limited to a maximum of 10 people across different demographic and stakeholder groups. They are not webinars, but participant-led group meetings to allow you to explore every facet of digital health with peers.
How can I become a member of the Digital Health Community?
We invite you to create a free account on our Community Hub to have a look behind the curtains. We'd love to show you the platform in a personal call. Click here to schedule a free session with a member of our team.
When can I access the Meeting recording?
Our Meetings are all about honest, open discussions. This is why we do not record our them. After each Meeting, if you were a participant, you will receive a link to the key takeaways; a short summary of the Meeting.
I am participating in this meeting, but can't attend anymore. Can I cancel it?
It can always happen that you cannot attend meetings due to unforeseen reasons. Due to the small group size, even missing one person can be disruptive. We'd like to ask all participants to inform us with at least 48 hours notice or suggest a suitable replacement for themselves.
Masterclass: The regulation of SaMD in Europe
Masterclass: The regulation of SaMD in Europe
Masterclass: The regulation of SaMD in Europe
Are you trying to get your SaMD product regulated in Europe? Keep reading, this masterclass is for you!
Regulation is an absolute essential for digital health companies who want to be accepted into clinical and payer groups. What are the must know and do’s and don’ts when attempting to take your SaMD product through regulatory pathways in Europe? Join us in this Masterclass led by S3 Connected Health to learn more about:
- Overview of current regulations that govern the SaMD products in Europe & General requirements from regulatory bodies
- The evolution of Europe regulatory regimes for SaMD & Current classification: EU Medical Device Regulation (MDR) vs. the old Medical Device Directive (MDD) & Local Considerations (non-EU countries like the UK).
- Recommended approach when engaging with European regulators: who to talk to, timelines constraints, etc.
- Changes expected in the European regulatory regimes for SaMD in the next few years
Join this group of peers and get a feel of what it's like to belong to a community of digital health gamechangers.
All meetings are limited to 10 people to allow for honest discussions, so apply fast or become a HealthXL member and get priority access to all meetings, latest industry reports and and much more.
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What are HealthXL Virtual Meetings?
HealthXL Virtual Meetings are private group meetings limited to 10 people across different demographic and stakeholder groups. For 75 minutes, you take a deep dive into your chosen topic and explore it from different angles. Virtual Meetings are not webinars: There is no audience, no recording and no hiding behind a screen. You actively participate in a discussion to solve your present challenges and design the future of digital health. And through our Community Hub, you stay up-to-date on the latest news and insights, allowing you to fully immerse yourself in the topic before, during and after.
How can I connect with other digital health leaders?
HealthXL brings together gamechangers of digital health to support honest discussions in small, private groups. In our Community Hub, for which you can register for free, you can follow a wide range of communities across telehealth, digital therapeutics, patient engagement and more. As a full HealthXL member, you also get access to curated news, the latest insights and an expert network to connect with. Join exclusive virtual meetings to exchange strategies, viewpoints and learnings with members from like-minded yet diverse stakeholder groups.
What are the benefits of being a HealthXL community member?
As member of HealthXL, you join a community of digital health thought leaders, innovators and game changers around the world. With your membership, you get access to hundreds of insights, reports and resources. You can browse a database with over 90k healthcare organizations and view their active strategic partnerships, commercial relationships, latest funding rounds and research. Through our in-house curated digital health newsfeed, you stay informed on the most impactful news and you can regularly meet with members to share learnings, discuss the latest developments and connect with peers of different demographical stakeholder groups. Contact us today to find out about pricing options.
Through focus groups, we bring together 6-10 thought leaders and industry stakeholders in a series of virtual meetings to collaborate around a defined topic. Each meeting gives the group the opportunity to examine, analyze and collaborate with one another around a digital health topic as well as produce a shareable result.
