Elina Tenhunen works at Measurlabs as a medical device testing expert. Her main focus is on coordinating customer projects related to EU MDR compliance and ISO 10993 standards.
Before joining Measurlabs, Elina worked in pharmaceutical industry quality assurance for five years, familiarizing herself with European medical device regulations, GMP guidelines, and biological analysis techniques.
Elina holds a master’s degree in biology, with physiology and neuroscience as major subjects. Her master’s thesis focused on neurological disease modeling with CRISPR/Cas9 gene editing technology.
Articles in other media
Elina has written about medical device testing for industry publication Lab Worldwide:
Elina’s latest articles in our blog
June 4, 2024
The role of the Biological Evaluation Plan (BEP) in the biocompatibility evaluation of medical devices
Preparing the BEP before large-scale testing starts helps companies choose the most appropriate testing procedure, which in turn helps minimize animal testing.
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March 21, 2024
Medical device testing for 510(k) submission to the FDA
Characteristics to be tested for 510(k) premarket submission include sterility, shelf life, biocompatibility, and mechanical performance.
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February 14, 2024
Alternatives to animal testing in the development of medical devices
The safety and legal compliance of medical devices can often be assessed without resorting to animal testing, especially in lower-risk device categories.
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