Today we summarize the profile of the ''Art. 15 Man''!Today we summarize the profile of the ''Art. 15 Man''!
Industry Insights
Industry Insights
EU-MDR introduces the requirement to add additional information on labels, therefore, mandates the re-design of label templates in order to incorporate the extra info
as well as the revised and/or new symbols introduced by the ISO-15223, which is currently under development.
Bayesian statistics is an approach for learning from evidence as it accumulates.
In clinical trials, frequentist statistical methods may use information from previous studies only at the design stage as in data analysis stage, this information is treated as complementary and not part of the formal analysis.
This is a searchable Excel spreasheet to make assignments of applicable FDA product codes easier and faster!
The IVDR redefines and introduces a new conformity assessment for companion diagnostics (CDxs), upclassifying them to class C.
Companion diagnostics now have stricter performance requirements and the need for clinical evidence.
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