Group Leader – Human Health

IN-Person

Marco Costante is a biological safety professional at knoell. He helps manufacturers to navigate through the intricate regulatory requirements to evaluate the biocompatibility of their devices. He has large experience in submitting medical devices worldwide, dealing with notified bodies, national agencies and ethics committees. He has a background of materials science and postgraduate education in toxicology, he is an active member of the ISO TC 194 following the development of ISO10993-1, ISO10993-17 and ISO10993-18. His membership to the international tables makes him a valuable source of information for manufacturers seeking for advices on strategies anticipating future trends and requests

Junior Engineer

IN-Person

Since 2020 and ongoing at the OFI with focus on animal free risk assessment of medical devices and food contact material.

Since 2022: PhD candidate at the TU Vienna.

2018-2020 at EUROFINS FOOD ANALYTICS AUSTRIA Food analytics, Sensory expert and customer support.

Junior Engineer

IN-Person

31/01/2021 ongoing Junior Engineer – microbiology and cell culture. 
Testing biocompatibility of medical devices (irritation, sensitization, cytotoxicity).
Set up of new qPCR methods.

01/05/2020 – 31/01/2021 Master thesis position – OFI Development of in-vitro bioassays to ensure endocrine safety of recycled food contact materials.

01/03/2018 – 30/04/2020 Laboratory technician – Thermo Fisher Scientific,
Vienna. Mainly within the production, e.g.: ELISA coating, lyophilization, bulk production.

10/07/2017 – 08/09/2017 Internship – Antibody engineering – SUT, Thailand
Using PCR, phage display, ELISA, Western Blot, SDS-PAGE to find antibody fragments (scFv) against glycoproteins on AML cells.

Invitro Laboratory Manager

Eurofins

IN-Person

Francesco has a degree in molecular biology and has been involved in research, development and validation of in vitro experimental models (author of some publications as posters and articles). After having held the role of Study Director for the in vitro safety evaluation for several years , today he holds the position of laboratory manager.

Biocompatibility Consultant

Intrinsic Medical Group, LLC

IN-Person

Marina Daineko is a Biocompatibility Subject Matter Expert at Intrinsic Medical Group, USA. In this role she is responsible for the biocompatibility evaluation for medical devices and materials for purposes of product registration and safety assurance. Marina holds a MSc in Analytical Chemistry.

With over eight years of medical device experience, a knack for understanding chemistry and an insatiable appetite for helping others use biocompatible products, Marina knows how to rock an evaluation, connect different pieces together and apply a risk-based approach. When not evaluating, Marina can be found creating delicious meals and bribing her snobby Pit Bull with treats in exchange for snuggles.

Senior Biocompatibility Specialist

Stryker

IN-Person

2021 Performance Excellence Award Winner at Stryker, I’m a Senior Biocompatibility Specialist with a strong background in Regulatory Affairs. I hold a PhD degree in Biological Sciences, completing a Master of Science degree in EU Regulatory Affairs. More than 10 years of research experience in the biomedical field acquired at renowned institutes across the globe.

Independent Biocompatibility

Consultant

IN-Person

Emilienne Zuyderhoff is a senior consultant with over 9 years of medical devices experience, holding different key positions as Design and Development Project Manager, Quality and Regulatory Manager and Biocompatibility SME. She has extensive experience in conducting risk assessments, including a risks-based approach to quality management systems per ISO 13485, Medical device risk assessments per ISO 14971 requirements and evaluation of biological safety of medical devices within the frame of a risk management process per ISO 10993-1 and FDA biocompatibility guidance. She has expertise in preparing evaluation strategies to address biocompatibility of devices including active devices, implantable devices, devices using animal tissues, and reusable devices. She is currently contracted as biocompatibility SME at Baxter Healthcare to support the pre-clinical team with MDR remediation activities of Renal Care/Acute Therapies medical device product portfolio.

She has a Ph.D. in Physicochemistry-Biomaterials Sciences, and an M.S. in Bioengineering from Université Catholique de Louvain (Louvain-la-Neuve, Belgium). Her research focused on the study of the cell-materials interactions, in particular, the impact of heterogeneous surfaces at the nanoscale on the cellular response, in the frame of the development of new biomaterials.

Microbiology and Biocompatibility Director

IN-Person

Estibaliz Arcaraz Basaguren is an experienced subject matter expert in Microbiology, Sterilization, Cleaning and Biocompatibility. She’s been working for twenty (20) years in Quality Operations and Product development Quality (QMS, Sterilization, Biocompatibility, Cleanrooms management, Risk management, Manufacturing Support and Release, Continuous improvement projects) in Medical device companies and Pharmaceutical Industry. She is an active member of AdvaMed Biocompatibility and Sterilization working groups. Responsible for supporting products’ certification and registration in all geographies, Estibaliz is currently acting as Microbiology and Biocompatibility Director for MicroPort Cardiac Rhythm Management division as well as independent Biocompatibility Consultant assessing several risk class products.

Independent Consultant

IN-Person

Micaela is a Biomedical Engineer and PhD with several years of experience working with biomaterials and biocompatibility. Micaela is the author of several papers about in vitro cytotoxicity evaluation of biomaterials. During the last years, she also developed, tested and validated different materials with antimicrobial properties.

After the PhD, she made the transition from academia to industry, where currently works as R&D Engineer in the topic of surface treatment with antimicrobial solutions.

Toxicologist / Biocompatibility SME

IN-Person

Joeri Lambrecht has a Ph.D. and M.Sc. in Biomedical Sciences from the Vrije Universiteit Brussel (Brussels, Belgium). After experience as toxicologist in the consumer industry, he has currently a key position as biocompatibility SME and toxicologist at Baxter Healthcare to support the Medication Delivery medical device product portfolio. He has strong interest in ex vivo alternatives of biocompatibility test methods.

Scientist

IN-Person

After completion of his doctoral studies in human physiology at the University of Zürich, Philippe Hasgall has been working within the medical device field within different roles. Currently, Philippe Hasgall holds the position of a Staff Scientist at Zimmer Biomet, a world leader in musculoskeletal health care, where he is responsible for biocompatibility evaluations and serves also as a scientific advisor globally for biomedical questions. Philippe A Hasgall holds a B.Sc. degree in biology and environmental science and a M.Sc. degree in Immuno-pharmacology, both degrees received from the Hebrew University in Jerusalem, Israel.

Senior Scientific Director

IN-Person

European Registered Toxicologist with a M.S. in Applied Toxicology and Biomedical Engineering, Paolo has over 15 years of experience in biological evaluation of medical devices and toxicological risk assessment for pharmaceutical products. He is member of ISO TC 194 and CEN TC 206 and adjunct professor at the University of Milan and Fondazione Alma Mater of Bologna. He is a former Health-care Engineering HAS consultant for EU Commission.

Clinical Expert

TÜV Rheinland

IN-Person

Clinical expert at TÜV Rheinland LGA Products GmbH (NB 0197) since 2015. Global head of the TÜV Rheinland Technical Competence Center clinical evaluation. Board licensed specialist physician for trauma and orthopaedic surgery with approximately 10 y of clinical experience. Participated in the evaluation and drafting of guidelines and position papers in the context of Team-NB. Auditor for ISO 13485, MDD and MDR.