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Wound Care Devices, Healthcare/Medical Equipment reimbursement/pricing, Healthcare claims Audit
Expert has worked in the medical equipment/wound care equipment field for more than 20 years. He has developed a unique wound treatment bed system, as well as helped other equipment manufacturers develop new equipment and provided consulting assistance with applying…
Medical Device Product Management, Product Launch, Marketing, Sales, and Sales Operations
Expert has over 30 years commercial experience in medical and diagnostic device product management and development, marketing, sales, operations, distribution and finance as an individual Contributor, Director, Vice President and CEO. Expert provides strategic advice to start-up medical device companies,…
Medical Device Strategy, Up-stream Marketing and Commercialization
Expert has over 30 years marketing experience in the healthcare industry. During his career he has launched over 20 products in the USA and internationally. Products launched include electronic medical equipment, durable medical equipment, medical plastic consumables, and medical software.…
Medical Device Design Control and Software Validation
Expert has extensive medical device engineering development and regulatory experience. He is a certified Lloyds of London ISO 9000 Lead Auditor and a member of the Westlaw Roundtable Expert Witness Network. His regulatory experience is primarily in product development, design…
International and Domestic Medical Devices, Sales/Distribution, QA/RA Compliance
Expert thrives on overcoming the quality and regulatory hurdles in the most time-efficient and cost-effective manner possible. He speaks fluent FDA, MDD and ISO 13485 and can converse successfully in CMDCAS, PAL, TGA, SFDA and KFDA as well. Whether you're…
Orthopaedic Surgery
Expert is board certified in Orthopaedic surgery and sports medicine by the American Board of Orthopaedic Surgery and the American Academy of Orthopaedic Surgeons. He was trained at the University of Kentucky in general surgery and Orthopaedic surgery, practicing at…
Adult and Pediatric Rehabilitation Medicine
Expert is board certified in physical medicine and rehabilitation with a specialty in pediatrics. She received her MD from Dartmouth Medical School in 1984 and completed her internship in pediatrics and resident training in physical medicine and rehabilitation in New…
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 Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new product introductions. A committed professional…
Hand Injuries, Hand Tool Design, Ergonomic Issues, Work Related Injuries in Dental/Medical
Expert is a certified associate ergonomist. Expert is founder and owner of a nationally based ergonomic consulting firm. Expert's background in ergonomics has allowed her to utilize her skills in preventing work related accidents and in assisting with the development…