mdi Consultants Inc.
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mdi Consultants Inc. Details
mdi Consultants Inc. is the leading provider of quality assurance, regulatory compliance and clinical services to the Medical Device, Pharmaceutical and Food industries. mdi Consultants, Inc., is a Medical Device Consulting, U.S. Agent, CE mark, ISO, Pharmaceutical and Quality Assurance, Regulatory Consulting company and Authorized Agent. Since 1978 mdiConsultants have been providing clients high-quality and high-value consulting services such as: FDA Compliance: regulatory strategy development, clinical trial development/ management, cGMP compliance, on site audits, validation (process, software and sterilization) and 510(k)/PMA/ANDA/NDA submission services 510(k) submission assistance Services FDA Trouble Shooting Services 483 & Warning Letter Responses Services Quality System Compliance Services CE Mark Consulting ISO compliance – ISO 9000:2000, ISO 14000, ISO 13485:1997 (EN46001), EN540 and Quality Systems, ISO Consulting Regulatory Consulting U.S. Agent Services Authorized Agent Services Import Agent Services European compliance – CE mark, Medical Device Directive (MDD), In-Vitro Diagnostic Directive (IVDD), and Active Implantable Medical Device Directive (AIMDD) Electronic drug listing and registration, FDA drug listing and registration, electronic listing and registration Health Canada compliance – medical device licensing, establishment licensing, private label licensing, label review, quality system ISO 13485 certification by CMDCAS recognized registrars
