Regulatory Services include:
All device manufacturers must also identify an Official Correspondent for FDA -
Who will be contacted by FDA, whenever the FDA has a question about the company or its products. This individual may be someone within the company or an outside consultant. As part of our on-going commitment to better serve our U.S. Agent clients, QSA, at the client's request, will also serve as their Official Correspondent at no additional charge. While it is acceptable to identify a company employee as the Official Correspondent, for reasons of language and time zone differences, FDA prefers to communicate with someone located inside the U.S.
Preparation and/or review of Establishment Registration and Device Listing forms
All device manufacturers must register all of their establishments and devices with the FDA, before the devices can be legally marketed in the U.S. These registrations must be updated annually or whenever a significant change occurs. As an additional service to our clients, QSA will prepare and/or review these forms and submit them to the FDA. Again, this service is provided at no additional charge, provided the client uses QSA as their U.S. Agent.
Finally, all manufacturers must comply with the U.S. Medical Device Reporting (MDR) regulations
Reporting Adverse Events. All product complaints must be assessed for MDR applicability. The reporting rules are complex with unique forms and requirements. They also change regularly. QSA will assist clients in assessing complaints received from the field and ensure that the proper procedures are followed and, if necessary, that the proper forms are completed and that the FDA is properly notified. There is no additional fee to sign up for this service, and all U.S. Agent clients of QSA receive a reduced rate for each complaint evaluation.
With over 24 years of US FDA and international regulatory and quality experience, Qserve America, Inc. working with the Qserve Group, B.V. and as a member of the One Link One Solution network, provides coordinated American and European regulatory and quality strategic planning, guidance and implementation from design and development through market launch, including all regulatory documentation and filings. These services are provided to medical device companies worldwide. Additional services include training in FDA regulations and project management, US Medicare reimbursement assistance, and identification of US distribution partners.
Contact us for our services, your questions, and our assistance. |
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