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Medical Device Consultants Inc. (MDCI)
49 Plain St.
North Attleboro, MA 02760
Tel: 508/643-0434
Fax: 508/643-2237
Web: http://www.mdci.com
E-mail: info@mdci.com
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Click below for the latest Medical Device Consultants Inc. Press Releases
| William Morton and John Webster Selected as RAPS Fellows | MDCI Welcomes Leslie Rose as Director, Clinical Project Management | MDCI Welcomes Jeff Roberts as Regulatory Consultant |
Corporate Overview
MDCI is a full-service consulting firm and contract research organization (CRO) that helps emerging and established firms commercialize novel and innovative medical devices, in vitro diagnostics, and combination products. Clients trust MDCI to deliver customized strategic guidance and creative "hands-on" solutions to address their unique regulatory, clinical trial, and quality assurance challenges at every stage of the product lifecycle.
MDCI has helped hundreds of clients conduct successful clinical trials, achieve regulatory clearance and approval, and maintain compliance for products in the U.S. and internationally. By leveraging our comprehensive knowledge of FDA and international regulations, clients capture and grow market share, increase productivity, and stay competitive in an increasingly complex global marketplace.
Put Our Expertise to Work for You
Regulatory Affairs
MDCI will help you with strategic planning for your new product introductions and product line extensions, regulatory management, and preparation of regulatory submissions. Read more about MDCI's regulatory services here.
Clinical Trial Support
MDCI can provide you with expert planning and management of multinational clinical trials, development of study materials, and preparation of clinical summaries for 510(k)s, PMAs, and CE mark submissions. Read more about MDCI's clinical services here.
Quality Assurance & Compliance
MDCI's QA & Compliance group will design, implement, and evaluate the systems and documentation you need to meet U.S. FDA Quality System regulations, ISO 9001 and 13485 standards, European Medical Device Directives, and Canadian Medical Device regulations. Read more about MDCI's QA & Compliance services here.
Speak with a Consultant
Reach our U.S. office at 1-508-643-0434, Monday through Friday, 9:00 a.m. to 5:00 p.m. Eastern. Or click here to have a consultant contact you directly.
Categories this company is listed under in the In Vitro Diagnostics Suppliers Directory:
- Consulting Services: Process Development and Validation (62 companies)
- Consulting Services: Quality Systems Certification (53 companies)
- Consulting Services: Regulatory Affairs (74 companies)
