Medical Device Management & Consulting consulting@regpromedical.com +1 (425) 241 - 3092
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We have experience in lead regulatory roles with manufacturing and distribution of
medical devices into over 90 countries worldwide.​
We have supervised and directed all aspects of compliance for
product portfolios of over 3500 medical devices including highly specialized ophthalmology surgical instruments and implants, ultrasound and other complex electrical and electronic devices,
sterile and single use devices, oncology clinical evaluation devices, to name a few.
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We have highly specialized background
Engineering ~ Advanced Auditing ~ Regulatory Science
Sterility Expertise ~ Combination Products ~ Clinical Evaluation
Six Sigma Strategies and proven track record in Cost, Waste & Risk Reduction
​​​​​We have unique background and expertise in Design & Development
from initial concept to launch
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We are well-versed in bringing North American Medical Devices
to the EU & the rest of the world
We organize compliance for International Medical Devices coming into the US & Canada from any and all countries and jurisdictions
and can act as your US FDA Agent
Let’s Work Together
Get in touch so we can start working together.