This presentation was delivered at the CPhI tradeshow in Madrid, Spain on June 14, 2018. Passports, ID cards, fingerprints, metal detectors, iris recognition, camera’s… we are trying to reveal the journey of “unknowns” to ensure safety and to avoid disaster. How is this different from an unknown in your drug product? Unknowns can pop-up during...
The regulatory environment for the biological safety evaluation of medical devices is changing rapidly. Biological safety evaluations following ISO 10993 have traditionally been addressed with biocompatibility testing on animals; however, alternate options are now available to reduce animal testing by using literature research and chemical characterization tests when appropriate. Additionally, there has been considerable progress in...
The regulatory environment for the biological safety evaluation of medical devices is changing rapidly. Biological safety evaluations following ISO 10993 have traditionally been addressed with biocompatibility testing on animals; however, alternate options are now available to reduce animal testing by using literature research and chemical characterization tests when appropriate. Additionally, there has been considerable progress in...
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