In Vitro Diagnostic Tests Regulation
By Dalia Givony Many diagnostic tests are frequently used for clinical diagnosis of human disease or conditions and in determination of...
ARTICLES BY DALIA GIVONY
Post Market Surveillance (PMS) under the new MDR
By Dalia Givony MDR (Medical device regulation, 2017/745/EU) was entered into force on May 25th 2017 with 3 years transition period for...
FDA Regulatory Approach to Clinical Decision Support Software
By Dalia Givony The need for Clinical Decision Support (CDS) using digital solutions and AI is rapidly growing and its benefits are clear...
Consulting with FDA under the Pre-Sub process before submitting a 510(k)/ De Novo
By Dalia Givony Manufacturers of medical devices and IVDs can obtain FDA feedback before investing their resources in expensive...
Labeling requirements for medical devices
By Dalia Givony Regulatory requirements for the medical device industry are constantly changing, which can be quite challenging for...