CB KALO Consulting





~ Paving the Way ~
Regulatory Compliance for your
Medical Devices



Our services




Clinical Evaluations






Clinical Evaluation Reports (EU MDR, FDA, UK MDR)

Periodic Safety Update Reports - PSURs

Post-market Clinical Follow-up - PMCF


Biological Evaluations






Biological Evaluation Reports according to ISO 10993 series

Providing guidance and toxicological information

on hazard, exposure and risk




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CB KALO consulting

CVR 39057859



E-MAIL: info@cb-kalo.dk