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  • manolo replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 6 years, 8 months ago

    If I am working with a biomaterial that has never been used before, I shall do every single test that I can think of. Starting with all of the ISO 10993-1 standards. The reason being is the amount of liability that I will have if ANYTHING goes wrong that I had no idea would happen (but should have). When moving into uncharted territory, utilizing your best performance of duty is even more essential than normal. You want to get it right or as close to right as possible so that as you move forward, you will have a better idea of what’s going on. I wouldn’t stop at just the standards either. Other tests that I feel would be beneficial will be conducted as well. I would rather have a large pool of information to reference back to vs not having enough data.