Phil Triolo And Associates LC

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Phil Triolo and Associates (US Agent) provide services to Medical Device, IVDD, and Combination Product companies. We prepare DMFs (in eCTD format) and other regulatory submission including 510ks, Q Subs, PMAs, IDEs, and de Novo Petitions to assure rapid US FDA authorizations; and Technical Documents to meet MDD / MDR requirements for CE Marking. We also implement and audit quality systems meeting ISO13485:2016 and 21CFR820 requirements.

Company Details

Address
86 Skycrest Lane
Salt Lake City, UT 84108

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