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Author: Helin Räägel





April 7, 2022

Biocompatibility Fundamentals for Medical Devices eBook

This eBook contains guidelines for planning, risk mitigation, testing, and compliance for the design and manufacture of medical devices. It provides a digest of pressing challenges and solutions for medical-device design, development, and testing with regard to biocompatibility and toxicology...

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February 14, 2022

Cytotoxicity Failure – What Now?

Cytotoxicity endpoint is marked for all medical devices that contact the patient/user, regardless of type or duration of contact. A cytotoxicity test is an in vitro cell culture assay where the medical-device extract is placed in contact with mammalian fibroblast...

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June 3, 2021

The New and Improved ISO 10993-12:2021—What Is Really Changing?

Every time there is an update to a standard, especially an overarching one like the ISO 10993-12 standard that covers sample preparation recommendations, it comes with a slight dose of anxiety. This is because it might mean there is now a...

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May 26, 2021

Medical Device Industry Approaches for Addressing Sources of Failing Cytotoxicity Scores

To ensure patient safety, medical device manufacturers are required by the Food and Drug Administration and other regulatory bodies to perform biocompatibility evaluations on their devices per standards, such as the AAMI-approved ISO 10993-1:2018 (ANSI/AAMI/ISO 10993-1:2018). However, some of these...

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May 26, 2021

26th of May 2021, A Day Many Medical Device Manufacturers Will Never Forget…

It is D-day, or the Day of Application (DoA) for the Medical Device Regulation (MDR) EU 2017/745. Years of hard work have preceded this date to prepare for this new regulation. The key message of the MDR is to minimize...

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