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Fda consultant medical device. Assisting the medical device community with fda regulatory services. Medical device regulatory consulting smith associates are consultants specializing in medical device regulatory affairs for fda compliance and have extensive experience and success in all aspects of the regulatory processes of 510 k pre submissions ides and pma bla submissions. Fda regulates the sale of medical device products in the u s. Working worldwide since 1990.
The weinberg group s comprehensive medical device consulting capabilities. Our firm delivers results faster. All foreign establishments must notify the fda of the name address and phone number of their u s. From consulting services by experts to training well over 4000 medical device employees we have the expertise knowledge to get the job done right.
Years of experience mixed with strategic approaches allow you to maintain project control while accessing the specialized medical device expertise you need 24 7. Our consulting capabilities include all regulatory and compliance aspects of device and combination product development. Is the leading provider of quality assurance regulatory compliance fda consulting and clinical services to the healthcare industry. Click here to view information from the fda on u s.
No matter what the device or how complex the device technology. The weinberg group is a full service fda consulting firm that provides an all inclusive medical device service offering. Under section 520 f of the act fda issued a final rule in the federal register of july 21 1978 43 fr 31 508 prescribing cgmp requirements for medical devices. Medical device consultants for ce marking us fda 510k registration listing en iso 13485 2016 and more.
Request a quote are you seeking fda clearance. For over 20 years we have helped thousands of medical device. Fda quality system fda regulatory compliance fda clinical services fda clinical services to the medical device pharmaceutical and food industries about us mdi consultants inc. And monitors the safety of all regulated medical products.
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