4th Annual Medical Device and Diagnostic Regulatory Affairs Conference
- 12th – 14th November
- Virtual
We Interact Together Innovate Together Inspire Together
Mastering MDR/IVDR: Proven Strategies, Seamless Compliance & AI-Driven Success
Key Topics For Regulatory Affairs
TRACK 1
European Market
(MDR/IVDR):
- EU MDR & IVDR Updates
- Post-MDR Medical Device Landscape
- EUDAMED Amendments
- Orphan Devices in the EU
- MDR & EU AI Act & Digital Health & IoT
- CE Mark Compliance
TRACK 2
Global Markets
(USFDA, APAC, EMEA REGIONS):
- Global Market Entry
- Navigating FDA and APAC Regulations
- Regulatory Challenges in Emerging Markets
- China’s NMPA/NHSA Framework
- ASEAN and APAC Regulatory Landscapes
- Global acceptance of CE-marked devices and valuable lessons learned
Why Attend a TT Conference
- 120 + Professionals from Medical Device Regulatory Affairs Departments only
- 35+ Solution Focused Sessions
- 16 Interactive Roundtable Discussions
- 10+ Hours of Networking
- 3 Days of Knowledge Sharing
- 2 Fireside Chats
- 1 Break-out Session
- Pre-Conference Workshop
Maximum Engagement
- Interactive Workshops
- Roundtable Discussions
- Fireside chats
- Speed Networking Sessions
- Presentations
Notified Body Speakers
Marta Carnielli
Head of Certification IVD
TÜV SÜD PRODUCT SERVICE GmbH
Dr Francesca Bevilacqua
IVD Team Leader
TÜV ITALIA S.R.L
Dr Saman Tavana
Senior Product Assessor
NOTIFIED BODY 1639, SGS, BELGIUM
Nunung Nur Rahmah
Notified Body Head of Internal Clinical Team
DEKRA PRODUCT TESTING & CERTIFICATION
Liz Gommans
Technical Professional
DEKRA PRODUCT TESTING & CERTIFICATION
Pre – Conference Workshop Speakers
Marta Carnielli
Head of Certification IVD
TÜV SÜD PRODUCT SERVICE GmbH
Nunung Nur Rahmah
Notified Body Head of Internal Clinical Team
DEKRA PRODUCT TESTING & CERTIFICATION
Venkata Harish Chengalvala
Sr. RA Specialist - Environmental Compliance and Regulatory Intelligence
THERMO FISHER SCIENTIFIC, INC
Kiran Jose
Sr Regulatory Affairs Specialty
ELEKTA
Targeted Content
With our targeted attendee and speaker line-up, you can have meaningful conversations with industry-specific experts who have faced the same situations and challenges. Spark new ideas by brainstorming during our breakout sessions, informal post-session Q&As, panel debates, case studies, and workshops.
Meet Industry Leaders
Our robust screening process ensures an exclusive environment where you can focus on connecting and fostering stronger working relationships with those in the medical device field. Collaborate to find the necessary solutions to your current problems.
Customize Your Content
Get the most out of this event experience by choosing what content is most relevant for you and your company and tailoring your event experience around this decision. Learn and connect with whomever you want, whenever you want, and however you want.
If you are a part of the Medical Device Regulatory Affairs community, TT RA guarantees a valuable return on time invested.
Silver Sponsor
Bronze Sponsor
Exhibition Sponsor
Roundtable Sponsor
You're In Good Company
