Roger White

Background

About Roger White

Roger White is the President of Phiama, Inc, a Regulatory Affairs and Quality Systems consulting firm serving the Medical Device Industry. Mr. White has a B.S. and a M.S. in Biomedical Engineering and has more than 35 years of experience in the Medical Device Industry. Previous positions include Vice President of Clinical and Regulatory Affairs for Cerapedics Inc, COO and Vice President of Clinical and Regulatory Affairs for Spine Wave, Inc, and Vice President of Product and Technology Development for Medtronic Surgical Navigation. Mr. White has extensive experience in the FDA regulatory approval process, the CE Mark process, and ISO 103485/FDA-based Quality Systems. Mr. White has successfully obtained more than sixty 510(k) clearances, including “first 510(k)” clearances for eight different early stage companies. His 510(k) clearances have included devices in Image Guided Surgery, Radiation Therapy, Diagnostic Radiology, Microwave Ablation, Orthopedics and Spine, Endoscopy, and Cardiovascular. He successfully obtained PMA approval for a spinal bone graft substitute in late 2015 for Cerapedics Inc.