Meet our speakers at the Biological and Clinical Evaluations Conference for Medical Devices

September 5, 2023

We are excited and proud to have some of the most experienced speakers within the industry present at our Biological and Clinical Evaluations conference in Copenhagen on the 4-5th of October.

Meet our speakers:

Lisa Moloney, Principal Technical Specialist & Scheme Manager, Orthopaedics & Dental , BSI Notified Body
Biological evaluation over the life cycle of a medical device – Aspects to be considered

Danielle Giroud, Founder, CEO, MD Clinicals SA
Clinical evaluations and investigations – how to align from a risk perspective

Crystal D’Silva, Senior Manager, Pre-Clinical Toxicology, Baxter International Inc
Proposed revisions to ISO 10993-1: Renewed guidance recommendations illustrated through a case study using true risk assessment approach for the biological safety evaluation of a hemodialyzer.

Gianluca Colucci, In-house Clinician, Intertek
Is it good enough? An interactive conversation among stakeholders in the certification process

Jan Peeters, Founder & Senior Consulting Specialist, Peeters MD Consulting
Planning comprehensive toxicological evaluations by linking ISO 10993 part 17 with part 18

Stefan Roth, Professor of product development/construction Applied plastics technology, Hochschule Schmalkalden University of Applied Science
Medical Grade Plastics – Requirements and Regulations on Plastics for Medical Applications

Ulrika Andersson, Chief Compliance Officer, Colzyx
Is a regulatory high-risk device a high risk for the patient?

Stefan Jernberg, Chief Regulatory Officer, Cuviva
The path to MDR Class IIa Certification of a Medical Device Software

Sofia Segersson, Entrepreneur, influencer, founder,
How life improves when the gadgets improve

Peter Löwenhielm, Innovation advisor Life Science, KI Innovations
Lost in translation: Navigating the regulatory landscape from bench to bedside

Ina Schäffner, Medical Science Liaison, Abilia
Getting your product to the market – how clinical evaluation can support Reimbursment and Health Technology Assessment (HTA)

Louise Hansen, Pharma and MedTech coordinator, Region Nordjylland, Denmark
How hospitals and companies collaborate in Denmark on clinical investigations

Maria Lyse, Clinical Research Specialist, Ambu A/S
The literature route to clinical data – a case of equivalence

Maria Lindgren, Director, Clinical development, Key2Compliance
Is it good enough? An interactive conversation among stakeholders in the certification process

Read more about the conference, the speakers, the possibility to network, and how to get your tickets HERE.

We hope to meet you in Copenhagen on the 4-5th of October!



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