4^th Annual Medical Device and Diagnostic Regulatory Affairs Conference

We Interact Together Innovate Together Inspire Together

Regulatory Revolution: Driving Innovation Across EU MDR & IVDR, and Global Markets!

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

Notified Body Speakers

Marta Carnielli

Head of Certification IVD

TÜV SÜD PRODUCT SERVICE GmbH

Nebojsa Serafimovic

Assessor, CIE-Member

AGES - AUSTRIAN AGENCY FOR HEALTH AND FOOD SAFETY

Dr Francesca Bevilacqua

IVD Team Leader

TÜV ITALIA S.R.L

Hamidreza Alidousti

Orthopaedic and Dental Team Manager

NOTIFIED BODY 1639, SGS, BELGIUM

Nunung Nur Rahmah

Notified Body Head of Internal Clinical Team

DEKRA PRODUCT TESTING & CERTIFICATION

Annette Van Raamsdonk

Lead Quality Regulatory Affairs

EMERGO BY UL

Pre – Conference Workshop Speakers

Marta Carnielli

Head of Certification IVD

TÜV SÜD PRODUCT SERVICE GmbH

Caroline Alexander

Director Of QA/RA

GENEDRIVE

Venkata Harish Chengalvala

Sr. RA Specialist - Environmental Compliance and Regulatory Intelligence

THERMO FISHER SCIENTIFIC, INC

Kiran Jose

Sr Regulatory Affairs Specialty

ELEKTA

Adam Gregory

Head of Regulatory Affairs

COLOPLAST

Nunung Nur Rahmah

Notified Body Head of Internal Clinical Team

DEKRA PRODUCT TESTING & CERTIFICATION

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.