Speakers

Melania Battistella
Prof-Master Aesthetic and Regenerative Medicine- La Sapienza University- Rome, Italy
Prof. Melania Battistella- Aesthetic Doctor, MD Global Manager Aesthetic Products Cosmetics Clinical Reviewer at Clinical Centre of Excellence, TUV SUD…
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Elina Buitrago
MD-Clinicals, Switzerland
Elina Buitrago is a Medical Writer at MD-Clinicals where she specializes in clinical evaluation of medical devices for CE certification.…
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Marta Carnielli
Head of Certification IVD, TÜV SÜD Product Services, Germany
Marta Carnielli works for TUV SUD as Head of Certification IVD; in this role, she is responsible for the certification…
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Bethany Chung
Clinical and Post Market Practice, RQM+, USA
Bethany has a Ph.D. in biomedical engineering and loves all things quantitative. She has more than 10 years of experience…
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Maria E. Donawa
President, Donawa Lifescience, Italy
Maria E. Donawa, MD is President, Donawa Lifescience, headquartered in Rome, Italy, with over 30 years’ regulatory experience, including six…
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Carlos Galamba
Founder of MDx CRO & VP IVD Intelligence & Innovation, RQM+, Barcelona, Spain
Carlos Galamba is a seasoned professional in the diagnostics industry, with a wealth of experience in both consultancy and regulatory…
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Danielle Giroud
CEO, MD-Clinicals, Switzerland
With over 30 years of experience within the medical device industry, Ms. Danielle Giroud is founder of MD-Clinicals ( https://www.md-clinicals.com),…
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Mark Grumbridge
Head of Clinical Investigations MHRA, UK
Mark is a registered general nurse and qualified in 1991. He is currently the Head of clinical investigations at MHRA…
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Muna Kebede
Director of Regulatory Affairs and Clinical Studies, Akra Team, Germany
Muna Kebede is a Senior Consultant at AKRA TEAM GmbH, a company which was founded in 2021 to support various…
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Priscilla Lemes
Regulatory Affairs Specialist, Edwards Lifesciences, Brazil
Graduated in Science and Technology and holding bachelor’s in biomedical Engineer and Neuroscience by Federal University of ABC in São…
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Rachel Mead
Clinical Regulatory Lead, BSI Group, UK
Rachel Mead holds an Honours degree in Electronics and Electrical Engineering from the University of Glasgow and is a member…
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Tom Melvin
Associate Professor of Medical Device Regulatory Affairs, Trinity College Dublin, Ireland
Tom Melvin is Associate Professor of Medical Device Regulatory Affairs in Trinity College Dublin. Prior to this, Tom worked as…
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Helene Quie
Founder, Qmed Consulting, Denmark
Helene Quie has a master’s degree in science specialised within Cellbiology from the University of Odense. Helene has more than…
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Ivon Septriyana
Clinical Project Manager, MD-Clinicals, Indonesia
With over 15 years of experience in the healthcare industry, Ms. Septriyana is Clinical Project Manager for Asia Pacific (notably…
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Nebojsa Serafimovic
Assessor Medical Devices, Senior Expert, AGES / Austrian Agency for Health and Food Safety, Austria
Mr. Nebojsa Serafimovic is assessor for clinical investigations with medical devices and performance studies with in vitro diagnostics at the…
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Amie Smirthwaite
Senior Vice President, Intelligence and Innovation RQM+
Amie Smirthwaite has a PhD in biomedical engineering and undergraduate degrees in biomedical engineering and mathematics. She has 30 years’…
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Alexandra Stamati
Director, QA-PRRC, Medicon Hellas SA, Greece
Alexandra Stamati is the Quality Assurance & Compliance Director at Medicon Hellas, the leading IVD Reagent manufacturer in Greece. Prior…
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Li Xin
Clinical Project Manager, MD-Clinicals, China
Ms. Li Xin is a certified medical device healthcare professional with over 18 years of healthcare experience and an accomplished…
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