Medical Device Consultants Inc.
May 22nd, 2008 — admin49 Plain Street
02760-4153 North Attleboro, MA
USA
Phone: (+1-508)643-0434
Fax: (+1-508)643-2237
http://www.mdci.com
info@mdci.com
Company Figures
Number of employees 50-99
Area of business Services and Publications
Company Profile
Who We Are
In today’s global marketplace, the development and marketing of medical products is a highly regulated process with strict governmental requirements. Since 1980, Medical Device Consultants, Inc. (MDCI) has provided regulatory, clinical, and quality assurance consulting services to help medical device and diagnostic product manufacturers meet those requirements.
Read senior management and staff biographies
Review our product experience
With locations in the United States and Europe, our professional staff has extensive FDA, industry, and healthcare experience and a thorough understanding of medical device development and testing, governmental approval processes, and compliance and quality assurance systems.
To ensure the highest quality service to our clients, our U.S. corporate office achieved ISO 9001 certification from BSI in 1998. This was upgraded to the ISO 9000:2000 standard in 2003.
We help manufacturers develop and implement cost-effective strategies and programs to meet the US FDA regulations and European requirements for their specific medical products and business objectives.
MDCI delivers custom solutions to a wide range of companies– from start-up ventures to established multi-national corporations throughout the world.
Product Information
10.01 Reports and analyses
regulatory assistance 25.04.2008
MDCI provides a full range of regulatory assistance and support to medical device companies. We can help you develop and implement the most advantageous regulatory strategy for your medical device, and prepare and submit the necessary documents to regulatory agencies to obtain marketing clearance.
Our consultants have extensive product experience and skills in regulatory affairs and an in-depth understanding of FDA, Canadian, and European requirements for marketing medical devices. MDCI consultants include former senior regulatory affairs personnel from industry, as well as former senior FDA officials who were responsible for the review and approval of new medical devices.
With the combined experience and technical skills of our consultants, we can assist both large and small companies in bringing their products to market in the most direct, cost-effective manner. We can handle single projects, supplement your existing staff for specific tasks, or provide complete regulatory support for your company.
KEY REGULATORY SERVICES
Developing and Implementing Regulatory Strategies
Assess impact of regulatory environment and FDA policies
Design pre-clinical and clinical studies
Evaluate technical and clinical data
Communicate and meet with FDA
Preparing and Submitting Regulatory Documents
Investigational Device Exemption (IDE) applications
Pre-market notifications [510(k)s]
Pre-market approval (PMA) applications
Device reclassification petitions
Master files
Canadian device license applications
Technical files for EU marketing
Reviewing and Developing Instruction Manuals and Other Labeling for FDA Compliance
Providing Liaison with FDA
U.S. Agent Services
Temporary On-Site Regulatory Staffing and Support
European Regulatory Consulting
CE Mark Consulting Services
European In Vitro Diagnostic (IVD) Directive
European Authorized Representative
10.08 Logistic services
10.08.06 Consulting for health organisations
10.10 Technical equipment management, Test houses/Certification Bodies
10.10.02 Certification and testing of medical devices, quality assurance