FDA Quality Systems
FDA Regulatory Compliance
FDA Clinical Services to the Medical Device, Pharmaceutical and Food industries
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
- 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 certification
- Successfully prepared and submitted over a 1000 510(k) applications
- Earned a 100% success rate in first time ISO certification
- Successfully 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