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Experien Group enjoys an extremely high measure of success in its development and execution of global regulatory strategies for clients’ simple to complex medical devices and combination products.
Experien Group works with clients ranging from those who seek direction at the earliest stages of formulating regulatory paths to those who require assistance refining near-complete regulatory filings. Our services include:
 FDA interface and preparation for Pre-IDE meetings and other applicable communications- FDA submissions, including Investigational Device Exemptions (IDEs), 510(k)s, Humanitarian Device Exemptions (HDEs) and Premarket Approvals (PMAs)
- International filings including Canadian Medical Devices Regulations, Japanese Shonin, Australian TGA and others
- International product submissions including Design Dossiers/Technical Files for CE Marking and individual country submissions
- Product labeling including Instructions for Use and User Manuals
- State of California license applications, FDA facility registrations, and international license filings
(i.e., Health Canada CMDCAS)
- State of California and FDA Quality System inspection support
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