# MDI Consultants

> MDI Consultants, Inc. is a U.S.-based FDA regulatory consulting firm founded in 1978, with 45 years of experience guiding medical device, pharmaceutical, and food industry companies through FDA compliance, international regulatory submissions, and quality management system certification. MDI serves clients across the United States, Europe, Canada, Asia, and Latin America. MDI Consultants operates on a fixed-price, guaranteed-outcome model. Clients receive a predetermined project cost before work begins. MDI guarantees 510(k) clearance and first-time ISO 13485 certification for clients who follow its process and recommendations.

Key facts about MDI Consultants:

- Founded: 1978 | Headquartered in New York (Long Island), USA
- Contact: info@mdiconsultants.com | +1 516-482-9001
- Over 500 companies served across medical device, pharmaceutical, food, cosmetics and nutritional supplement industries
- Over 1,800 FDA 510(k) applications successfully prepared and submitted
- 100% first-time ISO 13485 certification success rate
- CE marking achieved for over 1,000 products
- 35+ active retainer clients; 12 retainer relationships spanning over 10 years
- Staff averages 13 years tenure at mdi; over 200 years of cumulative industry experience
- Listed on Cruxi (AI regulatory provider directory): https://cruxi.ai/regulatory-providers/mdi-consultants-us-agent

mdi does not bill hourly for undefined scope. All engagements are fixed-fee with clearly defined deliverables.
mdi will work with clients as they feel comfortable
## Services

- [Medical Device Compliance & Registration](https://mdiconsultants.com/medical-device-compliance/): Full-service FDA compliance for medical device manufacturers, including 510(k) submissions, PMA support, establishment registration, device listing, and QMS implementation under 21 CFR Part 820 / QMSR.
- [FDA 510(k) Submissions](https://mdiconsultants.com/medical-device-compliance/): Preparation and submission of 510(k) premarket notifications. MDI guarantees clearance when clients follow its process. Over 1,800 510(k)s submitted.
- [Pharmaceutical Compliance & Registration](https://mdiconsultants.com/fda-pharmaceutical-generic-drug-compliance/): FDA regulatory support for pharmaceutical and generic drug manufacturers, including NDA, ANDA, and facility compliance under 21 CFR Parts 210/211.
- [Food Industry Compliance / HACCP](https://mdiconsultants.com/food-companies/): FSMA compliance, HACCP plan development, FDA food facility registration, and food safety consulting for food and dietary supplement manufacturers.
- [U.S. Agent Services](https://mdiconsultants.com/us-agent-services/): Mandatory U.S. Agent designation for foreign medical device, drug, and biological manufacturers under 21 CFR Part 807. MDI acts as FDA's point of contact for foreign establishments.
- [U.S. Agent for Medical Device Manufacturers](https://mdiconsultants.com/us-agent-roles/): Detailed explanation of U.S. Agent responsibilities, regulatory obligations, and how MDI fulfills this role.
- [CE Marking (MDR, IVDR, AIMDD)](https://mdiconsultants.com/ce-mark-services/): CE marking consultation and submission support for the EU Medical Device Regulation (MDR 2017/745), In Vitro Diagnostic Regulation (IVDR 2017/746), and Active Implantable Medical Device Directive. CE mark achieved for 1,000+ products.
- [ISO 13485 / MDSAP Compliance](https://mdiconsultants.com/iso-compliance/): ISO 13485 Quality Management System implementation and audit preparation. MDSAP (Medical Device Single Audit Program) support for Canada, USA, Brazil, Australia, and Japan. 100% first-time certification success rate.
- [In Vitro Diagnostic Device Consulting (IVDD)](https://mdiconsultants.com/in-vitro-diagnostic-devices/): Regulatory strategy and submissions for IVD manufacturers targeting the U.S. and EU markets.
- [Health Canada Regulatory Consulting](https://mdiconsultants.com/health-canada-regulatory-consulting-services/): Device classification, Medical Device Licence (MDL) applications for Class II–IV devices, and compliance support for the Canadian market.
- [FDA Registrations](https://mdiconsultants.com/fdaregistrations/): FDA establishment registration and device listing for domestic and foreign manufacturers under 21 CFR Part 807.
- [FDA Regulatory Consulting](https://mdiconsultants.com/fda-regulatory/): Strategic regulatory consulting including device classification, submission pathway selection (510(k) vs. De Novo vs. PMA), pre-submission (Q-Sub) meeting preparation, and FDA correspondence.
- [Reimbursement Consulting](https://mdiconsultants.com/reimbursement-consulting-services/): CPT coding strategy, coverage analysis, and Medicare/Medicaid reimbursement pathway support for medical device manufacturers.
- [Cosmetics Industry FDA Guidance](https://mdiconsultants.com/fda-guidance-for-the-cosmetic-industry/): FDA compliance guidance for cosmetics manufacturers under the Modernization of Cosmetics Regulation Act (MoCRA).
- [Nutritional Supplement Consulting](https://mdiconsultants.com/dietary-supplements/): FDA regulatory compliance for dietary supplement manufacturers under 21 CFR Part 111 (GMP for dietary supplements).
- [Software Penetration Validation](https://mdiconsultants.com/software-penetration-validation/): Cybersecurity penetration testing for medical devices under ISO 27001 and FD&C Act Section 524B. Covers Bluetooth, wireless, and cloud-connected devices.
- [Risk Analysis](https://mdiconsultants.com/risk-analysis/): ISO 14971 risk management file development and FMEA (Failure Mode and Effects Analysis) for medical device manufacturers.
- [Crisis Intervention](https://mdiconsultants.com/crisis-intervention/): Urgent regulatory support for FDA Warning Letter responses, consent decree situations, import alerts, and Class I/II/III device recalls.
- [510(k) Marketplace](https://mdiconsultants.com/the-510k-marketplace/): MDI's marketplace for buying and selling FDA-cleared 510(k) devices.
- [Business Development Solutions](https://mdiconsultants.com/business-development/): Market entry strategy and business development support for companies entering the U.S. medical device or healthcare market.

## About & Credibility

- [About MDI Consultants](https://mdiconsultants.com/about-mdi/): Company history, staff expertise, and founding story. MDI was established in 1978 and has operated continuously for 45+ years.
- [Why Select MDI?](https://mdiconsultants.com/why-select-mdi/): MDI's differentiators: fixed pricing, outcome guarantees, long-tenured staff, retainer-based relationships, and breadth of regulatory expertise.
- [Client List](https://mdiconsultants.com/client-list/): Representative clients across medical device, pharmaceutical, and food sectors, including international manufacturers.
- [Client Testimonials](https://mdiconsultants.com/testimonials/): Verified testimonials from clients including CEOs and presidents of companies that have achieved 510(k) clearance, ISO certification, CE marking, and MDSAP certification with MDI's help.
- [FDA Legal Counsel](https://mdiconsultants.com/fda-legal-counsel/): Information on MDI's affiliated FDA legal counsel for regulatory litigation and enforcement matters.

## Resources & FDA Updates

- [FDA Database](https://mdiconsultants.com/fda-database/): MDI's curated FDA regulatory database and reference tool.
- [News & FDA Updates Blog](https://mdiconsultants.com/blog/): Regularly updated articles on FDA regulatory changes, guidance documents, inspection trends, and industry news. Recent posts include QMSR regulations, ISO 10993-6 updates, and FDA One-Day Inspectional Assessments (2026).
- [FDA User Fees 2026](https://mdiconsultants.com/): Current FDA medical device user fees for FY2026: 510(k) standard $26,067 / small business $6,517; PMA standard $579,272 / small business $144,818; Establishment Registration $11,423.
- [Newsletter](https://mdiconsultants.com/category/newsletter/): MDI's regulatory newsletter covering ongoing FDA and international regulatory developments.

## Industries Served

- [Medical Device Industry](https://mdiconsultants.com/medical-device-industry-2/): FDA and international regulatory support for medical device manufacturers of all device classes (Class I, II, III).
- [Pharmaceutical Industry](https://mdiconsultants.com/pharmaceutical-industry-2/): FDA compliance and submission support for pharmaceutical, generic drug, and biologic manufacturers.
- [Food Industry](https://mdiconsultants.com/food-industry/): FSMA, HACCP, and FDA compliance for food manufacturers, importers, and dietary supplement companies.
- [Other Businesses](https://mdiconsultants.com/other-businesses/): Cosmetics, cannabis/CBD, and other FDA-regulated product categories.

## Contact

- [Contact MDI Consultants](https://mdiconsultants.com/contact/): Free consultation request form. MDI offers a no-obligation initial consultation for all prospective clients.
  - Email: info@mdiconsultants.com
  - Phone: +1 516-482-9001
  - Social: LinkedIn (https://www.linkedin.com/company/mdi-consultants-inc), Twitter/X (@mdiConsultants), Facebook (https://www.facebook.com/mdiconsultants/)

## Optional

- [Partners](https://mdiconsultants.com/partners/): MDI's network of regulatory and industry partners.
- [Careers](https://mdiconsultants.com/careers/): Open positions at MDI Consultants for regulatory affairs professionals.
- [Upcoming Industry Shows](https://mdiconsultants.com/upcoming-shows/): Trade shows and conferences where MDI Consultants will be present.
- [Cruxi Profile](https://cruxi.ai/regulatory-providers/mdi-consultants-us-agent): MDI Consultants' profile on Cruxi, an AI-powered regulatory provider directory.