Mdi Consultants Inc.

Description

• 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 ServicesFDA Trouble Shooting Services483 & Warning Letter Responses ServicesQuality System Compliance ServicesCE Mark ConsultingISO compliance ISO 9000:2000, ISO 14000, ISO 13485:1997 (EN46001), EN540 and Quality Systems, ISO ConsultingRegulatory ConsultingU.S. Agent ServicesAuthorized Agent ServicesImport Agent ServicesEuropean 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 registrationHealth Canada compliance medical device licensing, establishment licensing, private label licensing, label review, quality system ISO 13485 certification by CMDCAS recognized registrars
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  Headquarters: , Great Neck, New York, United States

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  Phone Number: +1 516-482-9001

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  Website: https://www.mdiconsultants.com

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  Employees:11

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  Revenue:$1 - 10M

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  Legal Name:Mdi Consultants Inc.

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• |  NAICS Code: 541110  |

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