Malene Nielsen

Senior Biocompatibility Specialist at 3Shape

Speaker

I am a Molecular and Medical Biologist from training now holding a role a Biocompatibility Specialist with the global medical device manufacturer Convatec. My journey in the field of Medtech and Biocompatibility started in 2019 within R&D in cross-functional positions with both a scientific expertise focus and focus on innovation, product development and life cycle management leveraging my scientific background within Human Biology. Patient safety is the core of my motivation, and I am highly driven by being able to ensure the biological safety of devices provided to users around the globe.

I am an ISO 10993 –Member of TC194 through DS and participate in WG01, 07 and 12 with involvement for development of standards related to Biocompatibility Evaluation and Testing within a Risk Management process and Evaluation of Systemic Toxicity. I hold multiple certifications related to Biological Evaluation & Toxicological Risk Assessment, and I am Certified ANAB ISO 17025 Lead Assessor.