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CORE–MD: A Path to Clearer AI Device Evidence Standards?
One of the most common questions our clients ask us is deceptively simple: "What level of evidence do we need for regulatory approval for our AI tool?" The answer isn’t always clear…
How To Conduct Due Diligence On SaMD And AIaMD Acquisitions
Expertise is needed to conduct thorough due diligence in the highly regulated and evidence-based healthcare sector. Hardian covers key clinical and regulatory points when conducting DD for investors, mergers, or acquisitions of an SaMD or AIaMD company.