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Author: Audrey P. Turley





May 7, 2021

In vitro Irritation

Every medical device on the market must be evaluated for its potential to cause irritation, from a knee brace to an artificial cardiac pacemaker, regardless of whether it has a short-term or long-term exposure to the user/patient. This is a...

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February 18, 2021

Requirements and Impact of the New Guideline – ISO 10993-23

The requirements for assessing irritation for medical devices has moved from ISO 10993-10 to ISO 10993-23 and with this new standard comes the inclusion of in vitro irritation testing as a recognized method. This is a critical turning point as...

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September 24, 2020

The suitability of reconstructed human epidermis models for medical device irritation assessment: A comparison of In Vitro and In Vivo testing results

Irritation testing is identified as one of the most performed biocompatibility tests for medical devices. This is due to the requirement for evaluation which is laid out in ISO 10993-1:2018: Biological evaluation of medical devices –Part 1: Evaluation and testing...

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April 1, 2020

Your MDR Strategy: Start with a Gap Analysis

The 566-page Medical Device Regulation (MDR), which replaces the EU’s Medical Device Directive (93/42/EEC) and the Directive on Active Implantable Medical Devices (90/385/EEC), has caused much discussion, training, debate, and stress in the medical device industry since its publication in...

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August 21, 2019

Understanding the EU Medical Device Regulation for Device Companies

The new European Union (EU) Medical Device Regulation (MDR) will impact medical device manufacturers’ product-development timelines. All companies intending to sell their devices in Europe must understand the new MDR and how it differs from the previous directives, especially in...

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