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Medical Device

June 18, 2021

An Ingredient List for Your Medical Device?

On May 20, 2021, FDA published a document (“Safety of Metals and Other Materials Used in Medical Devices”) requesting input regarding the best methods to use in conveyance of material information for a broader range of medical devices to both...

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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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November 27, 2018

Become Compliant with MDR as Soon as Possible

Medical devices marketed in the European Union are required to comply with a set of medical device directives called the “medical devices regulation” or MDR for their Conformité Européenne (CE) marking and marketing in Europe. Over the past decades, the...

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June 20, 2018

The Risk-Based “Big Three”

Incorporating Biocompatibility, Chemistry, and Toxicology into your Biological Risk Evaluation In the past, biocompatibility consisted of determining the contact of your medical device, looking at the Table A.1 in ISO 10993-1 and running the test prescribed. This approach put too...

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August 4, 2017

FTIR in Assessment of Medical Devices

Fourier transform infrared (FTIR) analysis is a popular analytical tool for material screening. The technique works because each different type of molecular bond in a molecule vibrates differently, and there is often a set of molecular vibrations that involve the...

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