510(k) / PMA submissions


UV-emitting devices and more...


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AEGIS FDA Listing Consultants Services Include:
* ISO 13485 Certification * Process Consultation on Medical Device Listing Submission * Listing Submission of 510(k) Exempt (Class I) Medical / Cosmetic Devices * Submission of 510(k) / PMA Applications for Class II and III Medical Devices * Submission of De Novo Device Applications i. a. FDAMA(97) * Clinical Testing of Medical Devices * In-House Spectral Analysis for Radiological Devices * IR, MCR, and AR Submissions in accordance with 21 CFR 1040 * Medical Device Production Record Maintenance * Submission of Appeals for Reclassification * Market Overview Research * ISO 9001 - 2008 Guidance