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