mdi Consultants Inc.

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 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 registrationHealth Canada compliance – medical device licensing, establishment licensing, private label licensing, label review, quality system ISO 13485 certification by CMDCAS recognized registrars Other industry-related services including 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:


Helped over 500 companies achieve FDA compliance and/or ISO certificationSuccessfully prepared and submitted over a 1000 510(k) applicationsEarned a 100% success rate in first time ISO certificationSuccessfully assisted obtaining CE mark for over 1000 products (Type IIa or above)Worked closely with CAMCAS on obtaining Canadian License for Class II and III medical device

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Monday	Open	9.00	4.30
Tuesday	Open	9.00	4.30
Wednesday	Open	9.00	4.30
Thursday	Open	9.00	4.30
Friday	Open	9.00	4.30
Saturday	Closed
Sunday	Closed