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MDI Consultants Inc - 510k Submission, FDA Regulatory Compliance Consulting Services, 483 Letters
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| Private Ownership
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55 Northern Blvd
Great Neck, NY (USA) 11021
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| Phone: |
516 482 9001 |
| Fax: |
516 482 0186 |
| Toll Free: |
800 448 4407 |
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mdi Consultants Inc. is the leading provider
of quality assurance, regulatory compliance and clinical services to the
Medical Device, Pharmaceutical and Food industries. Since 1978 we have
been providing clients the following high-quality and high-value
consulting services:
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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
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ISO compliance – ISO
9000:2000, ISO 14000, ISO 13485:1997 (EN46001), EN540 and Quality
Systems
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Crisis Intervention –
FDA audit response (483), warning letters, and product recalls
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European compliance – CE
mark, Medical Device Directive (MDD), In-Vitro Diagnostic Directive (IVDD),
and Active Implantable Medical Device Directive (AIMDD)
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Other industry-related
services – HACCP, In-Vitro Diagnostic Research and Development, U.S.
Agent (for non-U.S. companies), sales force performance improvement,
and marketing assistance
mdi leverages a proven and
tested methodology with seasoned and experienced consultants. With over
200 years of cumulative industry experience on staff, we have delivered
the following results:
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Helped over 500 companies
achieve FDA or ISO compliance
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Submitted over 400 510(k)s
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Earned a 100% success rate
in first time ISO certification
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Implemented over 150
complete quality systems
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Successfully assisted over
200 products (Type IIa or above) for CE Mark
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