Latest
Rule 11 vs MDCG 2019-11
Class I or not Class I that is the question
Is this really a Class I medical device?
Is segregation always necessary?
simplified software classification scheme according to MDR
MDSW intended for clinical scoring
Degree of autonomy vs Artificial Intelligence and Machine Learning
Reasonably foreseeable misuse and security
Guidance for manufacturers and notified bodies on reporting design changes and quality system changes
Reporting Adverse Events for a "Medical Device" That May Not Be a "Medical Device"
EHR vs Medical Device
CrowdStrike vs ISO 27001
