James Morrison

FDA

New Guidance on FDA ISO 10993-1

On 4 September 2020 FDA re-issued their guidance on the use of ISO 10993-1 and Biocompatibility. I don’t think anyone saw this coming. It’s a big surprise! But the good...
shutterstock_1130828387 (1)

Chemical Characterisation – no simple matter

Understanding Chemistry is now mandatory The most recent edition of ISO 10993-1 in 2018 added to the evaluation table (Table A.1) the interesting item “Physical and/or chemical information.” This is...
Molecular

Inaugural Course on Molecular Toxicology

Molecular toxicology is the discipline that particularly emerged in recent years as a result of the paradigm shift currently going on in the field of toxicology. This shift is the...
Wringing out

On Extraction – the vagaries

In previous articles, some months ago on LinkedIn, I discussed the process of extraction. That is the process of preparing a sample for testing (perhaps biological) from a test article...
TC194XBerlin

TC194 Wrap Up 2018

TC194 – The Big Wrap The ISO Technical Committee 194 is responsible for the biological and clinical evaluation of medical devices. The Annual meeting of TC194 was recently conducted in...

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