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
Company Details
- Founded
- -
- Phone
- 1-516-482-9001
- Industry
- Legal Services
- NAICS
-
Legal ServicesOffices of NotariesOther Legal ServicesTitle Abstract and Settlement OfficesAll Other Legal Services
- Website
- mdiconsultants.com
Mdi Consultants Inc. Questions
Mdi Consultants Inc.'s helpline number is 1-516-482-9001
Mdi Consultants Inc.'s website is mdiconsultants.com
Mdi Consultants Inc.'s LinkedIn profile is https://www.linkedin.com/company/mdi-consultants-inc-
Mdi Consultants Inc.'s industry is
Legal Services
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Mdi Consultants Inc.'s categories are Legal Services
Mdi Consultants Inc.'s founding year is 1978
