Marta Carnielli works for TUV SUD as Head of Certification IVD; in this role, she is responsible for the certification process for IVD medical devices as well ensuring accreditations, designation and authorization relevant to IVDs are maintained by TUV Sud.  

She is representing TÜV SÜD in regulatory committees and conferences and support management and technical experts with the interpretation of regulatory requirements. She is the Co-Chair of the IVD Notified Bodies Working Group 

Prior to joining TÜV SÜD, Marta worked for Ortho Clinical Diagnostics where she held various roles of increasing responsibility within Customer Technical Support and the Quality, Regulatory and Compliance department. 

In her most recent role she was Senior Manager, QRC EMEA; in this role she was responsible for quality, regulatory and compliance activities related to the commercial business in Europe, Russia, CIS, Africa and Middle East.

Corinne joined nexialist in 2020 as Regulatory Intelligence Director. She is an expert in European regulations based on 25 years hands-on working in the field, as auditor, regulatory affairs director, and Head of Notified Body. She has been an active member of Notified Bodies working groups (NBMED) and a member of the board of Team NB. She was involved in the development and implementation of the CDMCAS program, then the MDSAP (US, Canada, Australia, Brazil, Japan) bringing her inputs as representative of an auditing organization. Her current position and her previous operational and management positions since the beginning of her career within the French Ministry of Health forge her regulatory convictions and her understanding of the MD sector. She monitors opportunities in the current regulatory environment to shape future regulations or their guidances. She is an active member (and former chair) of the AFNOR S95B Commission « Quality Management and Related General Aspects of Medical Devices » and of the associated CEN and/or ISO Technical committees and working groups. She also develops educational sessions, presents webinars, and participates in conferences. 

Carlos Galamba is a seasoned professional in the diagnostics industry, with a wealth of experience in both consultancy and regulatory roles. He is the co-founder of MDx CRO and previously served as Vice President for Diagnostics at RQM+, one of the world’s largest consultancies fully dedicated to medtech. In this role, he was responsible for the overall strategic direction and subject matter leadership for diagnostics. Carlos also spent 7 years at the Notified Body BSI, where he managed, coached, and developed a global team of IVD technical experts. He was BSI’s first in-house clinician for IVDs, where he led the implementation of the BSI clinical oversight process, made hundreds of CE marking recommendations for IVDs and supported IVDR Notified Body designations. Prior to BSI, Carlos held roles at the UK competent authority, the MHRA, and was a lead scientist in the UK National Health System, specializing in transfusion and transplantation medicine. He played a key role in hospital and laboratory preparedness for emerging infectious diseases, including the Ebola crisis in 2014 when the first cases were detected in Europe. 

Dr Michaela Kauer-Franz studied psychology and completed her PhD in mechanical engineering at the Technical University of Darmstadt on « Acceptance of Technical Products ». After completing her doctorate, Dr. Kauer-Franz headed the « Product Design » research group at the Institute for Ergonomics and Human Factors at the TU Darmstadt. In 2013 she founded the data driven UX design agency Custom Interactions GmbH, with which she supports customers in the development of technical products in the areas of usability and user experience design and testing. Custom Interactions has since than implemented more than 300 successful projects and has been awarded or nominated for several design prizes (e.g. Red Dot Design Award Winner Interface Design, German Design Award, UX Design Award). Since 2017 she is head of the Custom Medical business unit, which specializes in usability engineering and testing for medical devices and in-vitro diagnostics and is ISO 13485 certified for this field. Ms. Kauer-Franz is a TÜV Rheinland certified Medical Devices Usability Expert and Risk Manager. 

In addition to her work as a founder and managing director, she passes on her knowledge of successful product design to others in the context of lectures, training courses and start-up schools. Dr. Kauer-Franz works in the national standardization committees of DIN on the standardization for all topics in the field of ergonomics, usability and user experience and is a lecturer for « Design of Human-Machine Systems » and « Design of Medical and Critical User Interfaces » at the Technical University of Darmstadt. Together with her husband Dr. Benjamin Franz, she is the author of the « Handbook Usability and User Experience Design » at Rheinwerk Verlag. 

Steve joined ABHI as Director of Diagnostics Regulation in 2020.

After completing his degree in Biochemistry and Biology at Aston University, Steve trained as a Biomedical Scientist, working in hospital microbiology before moving to industry to work as company microbiologist. Steve joined MHRA in 1996 when it was still the Medical Devices Agency and when the IVD Directive had yet to be implemented.

While at MHRA, Steve worked with manufacturers, Notified Bodies, other Competent Authorities, Trade Associations, standards bodies and government departments. Steve was Chair of the European Commission’s IVD working group when the IVD regulations where being developed.

In 2019, Steve was presented with the TOPRA award for regulatory excellence.

Dr. Sandra Neidhöfer studied biology at the Johannes-Gutenberg University in Mainz, Germany. After her PhD with the focus on molecular biology she worked for an international diagnostics company for 16 years. As a project leader she developed ELISA assays in the fields of autoimmune diseases, hemostasis and infectious serology and accompanied the products from the beginning of their life cycle to the post production phase.  

In 2022 Sandra joined Metecon’s IVD division in Mannheim. Here she provides detailed support for customer projects in the areas of regulatory affairs and technical documentation. One of her main points of interest is usability engineering. At this, she assists clients in the creation of their usability engineering files in accordance with requirements of the IVDR. And in addition, she is responsible for imparting knowledge on the topic of usability engineering at the Metecon Academy. 

To date, Sandra has acquired in-depth and comprehensive know-how and many years of experience in the field of regulatory affairs, and specifically on the regulatory requirements that IVDs must meet. In 2023, she and her team will give various lectures at the Mannheim University of Applied Sciences for the medical technology program. Metecon’s IVD team sees this as a unique opportunity to provide the next generation of regulatory affairs professionals with necessary and helpful knowledge for all upcoming activities. 

Metecon’s IVD division advises and supports manufacturers on IVD regulatory compliance at all levels and at any point in the product life cycle in order to meet the requirements of the IVDR and other country-specific regulations: in the development of a new IVD, in the maintenance of existing IVDs, in market entry into new target markets, in post-market surveillance and in the optimization of quality management processes. 

Dr. Julien Senac is currently Director of Medical and Health Services Americas at  TÜV SÜD. he has many years of experience with a certification body (TÜV SÜD & GMED), where he participated to the preparation of IVDR designation, and performed Design Dossier assessment of in vitro diagnostic devices. Dr Senac has a Ph.D. in Molecular and Human Genetics from Baylor College of Medicine (Houston, TX) and more than 10 years of experience in biomedical research. He worked in top research/medical institutions in the United States such as Mayo Clinic and the National Institutes of Health. Dr Senac has also participated to the development of multiple biotech start-up companies in oncology and gene therapy. 

Sue leads Qserve’s IVD service, is EU Regulatory and Quality Expert including CDx and Lead Auditor. She has over 30 years’ of experience in the Medical Device and IVD industries including extensive notified body experience 

Before Qserve, Sue has worked for several IVD companies ranging from start ups to large multinationals, where she has held positions in R&D, manufacturing and quality assurance. Sue worked for 3 Notified Bodies establishing two from scratch. 
Sue chaired the European IVD Notified Body Working Group coordinating the Notified Body responses to the regulations. Sue also participated in the Commission IVD Technical Work Group for many years. 
Sue is an experienced trainer on a variety of IVD topics and particularly enjoys creating workshops to improve hands on experience with the requirements.