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Regulatory
Assistance with medical devices and the US FDA.
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Delphi Consulting Group (DCG) provides comprehensive medical device US FDA
regulatory services. The following is a brief overview of services:
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Premaket Notifications --
DCG provides research, writing, monitoring testing, follow-through and/or
review of FDA 510(k)s, IDE and PMA applications. DCG produced
submissions have often resulted in less than normal review time. Submission
have been completed for device manufacturers located worldwide. A number
of recent submission have been completed for companies located in the Pacific
Rim area.
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NRC License
-- Licenses for sealed sources and Brachytheray devices, 10 CFR Section
30.32XX and 10 CFR Part 71 packaging and transportation of Radioactive
materials.
- Third Party 510(k) Reviews
-- DCG has working agreements with a number of authorized 510(k) Third Party
Review organizations.
- Sterilization Validation --
Product sterilization validation and re-sterilization validations.
Validate reuse devices for cleaning, and re-sterilization. Write
protocols, monitor testing laboratories and prepare completion report.
- EMI and Safety Standards (UL)
Testing -- Provide engineering review and agency listing of
devices. Act as agent for UL Listing. Monitor testing laboratory
activities and provide engineering feedback.
- Replies to FDA Form 483, Warning
Letters and Seizure Actions -- DCG has extensive
experience with preparing a strategy for reply and follow up actions.
- Reuse of Single Use Devices --
Premarket submission for Hospitals and Third Party Re-processors to
ensure compliance with regulations and laws.
- U. S. Agent --
DCG provides U. S. Agent Services for Foreign Establishments per 21
CFR 807.40.
- Electronic
Medical Devices Submissions -- DCG provides production of
electronic submissions for Medical Device Submissions to the FDA. Save
by outsourcing this need.
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