Medical Device Qualified Supplier Directory
MDI Consultants Inc. Company Profile
Qualifications: Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: North America, Europe, Worldwide
Contact: Alan Schwartz
Year Established: 1978
No. of Employees: 22
Key Clients: Client list supplied upon request.
FDA Quality Systems
FDA Regulatory Compliance
FDA Clinical Services to the Medical Device, Pharmaceutical and Food industries
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mdi Consultants Inc. is the leading provider of quality assurance, regulatory compliance and clinical services to the Medical Device industry. 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 Consultants, Inc. is an internationally recognized management consulting firm providing services to all size companies since 1978.
Our staff's expertise, in listening to our clients problems and concerns and using innovative strategies, has earned mdi the reputation of a company that cares about its clients. Our knowledge of FDA regulatory affairs makes mdi Consultants the leader in this area. mdi has customized over 400 quality systems for companies worldwide; and, more than 500 510(k)s have successfully passed FDA reviews. mdi Consultants is recognized by the FDA as an expert for third party certification. Our highly reknown reputation as FDA specialists is shown in our strategic planning in dealing with FDA problems such as issued FDA483s, Warning Letters and Injunctions - an ability which can only be developed after many years of successful experience with such regulatory actions. Our staff of former US FDA officials and industry experts provides mdi a powerful backbone of experience. In addition to FDA regulatory expertise, mdi works with companies in setting up their ISO9000 Program and Device Technical File for CE Mark Certification. We guarantee certification and have been able to achieve this certification on first time audit. Our strategic management planning used by companies for conducting due diligence, management review and future projection has been used by companies both large and small. mdi's innovative fee policy, set by pricing the work on a project basis rather than an hourly or daily rate, is a method that is now been widely accepted as the most favorable method of payment. With published articles, invited guests for industry seminars both domestically and internationally, mdi Consultants provides the highest level of professional services to all our clients worldwide.
For more information contact MDI Consultants Inc.