Elina Tenhunen

Medical Devices

MSc in Neuroscience & Physiology, Biology

Elina Tenhunen

Elina Tenhunen works at Measurlabs as a medical device testing expert. Her main focus is coordinating customer projects related to EU MDR compliance, ISO 10993 standards, and medical device packaging testing.

Before joining Measurlabs, Elina worked in quality assurance in the pharmaceutical industry for five years, familiarizing herself with European 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

February 21, 2025

Navigating medical device packaging testing according to ISO 11607

ISO 11607-1 and ISO 11607-2 lay down internationally recognized requirements for the packaging systems of terminally sterilized medical devices.

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Navigating medical device packaging testing according to ISO 11607
Elina Tenhunen
Elina Tenhunen

January 22, 2025

Cleaning validation of reusable medical devices: how to fulfill EU and FDA requirements?

Rigorous cleaning validation - conducted according to international standards - is crucial to ensure safety and obtain regulatory approval for reusable devices.

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Cleaning validation of reusable medical devices: how to fulfill EU and FDA requirements?
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

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