RegPro Medical Logo - medical devices

RegPro Medical

medical devices
China's Best One-Stop Medical Equipment Provider
About

RegPro Medical has recognized that there is now a gap need in the Medical Device Industry for qualified Regulatory and Quality Engineering services.  We specialize in Technical Documentation Engineering for MDR applications and also support QMS development at any stage of your organization's growth. RegPro Medical has supervised and directed all aspects of compliance for product portfolios of over 3500 medical devices and has had Lead Regulatory roles with manufacturing and distribution of medical devices into over 90 countries worldwide. Services Regulatory and Quality Medical Device Consulting & Management including: -Highly specialized niche of Technical Documentation Engineering for CE Marking -Advanced Auditing -ISO 13485, MDSAP & MDR support, concept to launch -for a full list see our website at https://www.regpromedical.com Our Mission To be the preferred choice, as Trusted Regulatory Partner, by Medical Device Manufacturers wanting to dominate in their market, excel in the major markets and reach for new international access. Our Vision A world where the best medical devices in the world are available worldwide

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Keywords
ce marking post market surveillance health canada capa regulatory affairs medical device consultant auditing quality system regulation 21 cfr part 820 mdsap iso 13485 2016 combination products fda technical documentation eu mdr quality management systems risk management design control clinical evaluation fda inspection recovery medical equipment manufacturing iso 14971:2019 quality management system b2b auditing & inspection sterility expertise international compliance auditing services iso 13485 risk analysis
Company Information
  • Employees 2
Location

2226 Eastlake Ave E, Seattle, Washington, United States, 98102-3419

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