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Veljko Kopjar Author
Subjects of specialization
Affiliation
Musculoskeletal biology, Cubosomal gel, Orthopaedics, Rickets
Director of Clinical Development, Clinipace Worldwide, Inc. North Carolina, USA
Biography
Veljko Kopjar was working as a Director of Clinical Development, Clinipace Worldwide, Inc. North Carolina, USA. He has more than 50 publications. His current research in Medical Devices used in the United States are FDA-Approved.
Publications
Editorial Open Access
A Broken Regulatory System: Only 2% of Medical Devices used in the United States are FDA-Approved
Author(s): Veljko Kopjar
When most people think of medical devices that are legally marketed in the United States and implanted or otherwise used by trained and licensed surgeons, they are very likely thinking of FDAApproved medical devices. FDA Approval incorporates rigorous preclinical research such as: cadaver, animal, mechanical, materials and stress testing followed by human subject trials that are aimed at proving that a device is safe and effective. The trials may include a pivotal trial preceded by one or more pilot studies, and an adequate number of months for clinical follow-up. Many devices (e.g., hipreplacement systems) usually require at least 24 months’ follow-up. In order for a company to pursue this pathway, it must first obtain an Investigational Device Exemption (IDE) which allows it to ... view more»
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