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Medical Device and Product Development Expert
Expert is a seasoned Engineering Leader with over 20 years of experience in Medical Devices, including Product Development and Product Management. He set up the Global Technology Centre for TE Connectivity and Medtronic in India and has established a Catheter…
Ultrasound
Seasoned medical device Research and Development professional practiced in leading cross-functional engineering teams, developing and executing technology roadmaps, and driving strategic expansion of intellectual property (IP) portfolios. Over 15 years of experience in product development, including ultrasound imaging systems, ultrasound…
Medical Devices
Expert has about 10 publications on ablation. He published papers on this area and had grants to develop radio-frequency cardiac and liver ablation systems. He founded and directed a laboratory for medical device testing under IEC standards. Overview of Skills:…
Cardiac Electrophysiology
Expert is an EHRA board Certified Electrophysiology Specialist [ECES] (2015) physician with a Ph.D on Atrial Fibrillation Ablation. He has worked on the request ofthe Ministry of Health of the Czech Republic to ensure qualified evaluation and administrative processing of…
Cardiac Electrophysiology, Cardiology Drugs, Pacemakers, Defibrillators, Cardiac Medical Devices
Expert. Expert is a board certified cardiac electrophysiologist (cardiologist with expertise in the diagnosis and treatment of all cardiac rhythm disorders) with over 20 years experience as a clinical investigator, IRB Chair, and high volume implanter of cardiac rhythm devices.…
Implantable and Non-Implantable Medical Device Risk, Safety, and Failures
He has experience in developing, writing, and submitting risk management related documentation to support Notified Body, 510k, PMA-S, and PMA submissions (Class I, II, and III). He has experience in the legal and safety requirements between 510k and PMA devices…
Medical Device Technology, Clinical Research & Business Development
Expert has decades experience in Multi-modality medical imaging: digital x-ray, ultrasound, IVUS, MRI, intra-operative MRI, multi-slice and cone beam computed tomography, hybrid PET/CT and SPECT/CT, optical coherence tomography (OCT), endo-confocal microscopy and fluoroscopy imaging. Furthermore, he has experience in Image-guided…
Medical Device Regulatory Submissions
She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic…
Medical Devices, Electronic Systems, Acoustics and Hearing, Intellectual Property
Because of his long-term interest in sound and hearing, Expert has been involved with many aspects of acoustic measurement. He has developed proprietary technology for sound level measurement and noise dose determination and has utilized his skills in acoustic measurement…
Medical Device Product Development; Machine Design; Biomedical Engineering
Medical device product development engineer. He performed research on adding an antimicrobial agent to a silicone rubber medical device molded using LIM. The research included materials, methods of molding, color changes, and effects on biocompatibility. His library contains many materials…