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Author: Thor Rollins





January 5, 2021

The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list

In October 2020 FDA released a new draft biocompatibility guidance document which focuses on the biological evaluation of devices in contact with intact skin. As a draft document, it is therefore open for comments and possible changes. Release of this...

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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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August 8, 2019

Choosing Colorants for Medical Devices

Colorants are often added to the substrates and material components of medical devices with the primary intent of improving the usability of the devices. For instance, color coding can assist users in matching devices or sizes together when multiple options...

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