Elina Tenhunen

Medical Devices

MSc, Biology

Elina Tenhunen

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

Elina Tenhunen
Elina Tenhunen

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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The role of the Biological Evaluation Plan (BEP) in the biocompatibility evaluation of medical devices
Elina Tenhunen
Elina Tenhunen

March 21, 2024

Medical device testing for 510(k) submission to the FDA

Product characteristics to be evaluated for 510(k) premarket submission include sterility, shelf life, biocompatibility, and mechanical performance.

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Medical device testing for 510(k) submission to the FDA
Elina Tenhunen
Elina Tenhunen

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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Alternatives to animal testing in the development of medical devices

Read articles by our experts and guest authors on the practical implications of regulations, scientific advancements, and the ideal uses of different analysis methods.