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Medical Device Establishment Registration Services In North America
7 services found
by:Proregulations based inSanta Clara, CALIFORNIA (USA)
U.S. FDA Medical Device Establishment Registration and Listing: DA has divided into two groups of establishments which is domestic and foreign establishments. In general, if you are a manufacturer of medical device must register and list the ...
by:Proregulations based inSanta Clara, CALIFORNIA (USA)
FDA Medical Device Registration: A medical device is difficult to classify since new technology and intended use, our regulatory consulting can help you to classify and determine the device in the united states, and we can process with your submission with FDA. Prepare the correct FDA submission and proper U.S. FDA classification of your device is extremely important to avoiding regulatory delays ...
by:Emergo by UL based inAustin, TEXAS (USA)
Commercializing your medical device first requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device. Device registration requirements can vary significantly from country to country, which can create compliance challenges for companies pursuing multiple-market strategies. Depending on where you plan to sell your device(s), ...
Manufactured by:Integrated Diagnostics Group, A division of Sanzay Corporation based inMiami Gardens, FLORIDA (USA)
IDG helps you approach the medical device market with ease of mind. We assist you with Medical Device and IVD Registration, local in-country representation, distributor qualification and quality system ...
by:Emergo by UL based inAustin, TEXAS (USA)
Regulators in most medical device markets require registrants to meet post-market surveillance (PMS) obligations to maintain compliance. However, PMS rules can vary between different medical device markets, requiring manufacturers to develop tailored rather than one-size-fits-all approaches. With deep expertise in post-market surveillance requirements, Emergo is equipped to act as your compliance ...
by:Chemical Inspection & Regulation Service Limited (CIRS) based inHangzhou, CHINA
Medical Devices and In Vitro Diagnostics Product Regulatory Compliance in China. Pre-market Investigation & Analysis. Medical Devices Registration & Approval. Clinical Trial Consulting. Manufacturing and Distributing License Approval. Quality Assurance & Compliance. Risk Assessment & Management. Customs Clearance. IPR Protection in ...
by:HingeClinica based inPrinceton, NEW JERSEY (USA)
HingeClinica is a world class partner for Medical Device services. We render End to End Medical device MDR compliance and Regulatory services, Clinical trial, Pharmacovigilance services to Medical Devices industry. Our Medical Device team has extensive experience in working with US FDA, EMA, PDMA, SFDA, Health Canada, DCGI and ROW, regulatory Submissions and ...