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Medical Device Consultants Inc.
49 Plain Street
North Attleboro, MA 02760 USA
Tel: +1 508 643 0434
Fax: +1 508 643 2237
Web: http://www.mdci.com
E-mail: info@mdci.com
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Corporate Overview
Whether you are just beginning the regulatory process, preparing a 510(k), PMA, or IDE for submission, developing a technical file and design dossier for CE marking, designing a clinical study, responding to an FDA warning letter or 483, or planning for a regulatory audit, Medical Device Consultants, Inc. (MDCI) is the company to call.
MDCI consultants have the expertise, knowledge, and experience to help you achieve the US FDA, European and Canadian marketing clearance or approval you need to bring your product to the marketplace. We can help you ensure that you have the systems in place to meet on-going FDA and ISO compliance requirements. And, we can serve as your European Authorized Representative and FDA US Agent.
Put Our Expertise to Work for You
Regulatory Services
MDCI will help you with strategic planning for your new product introductions and product line extensions, regulatory management, and preparation of regulatory submissions. Sheila Hemeon-Heyer, JD, RAC, Director of Regulatory Services, has over 17 years of regulatory experience, including positions at FDA, leads a staff with extensive and diverse scientific and regulatory experience. Read more about MDCI’s regulatory services.
Clinical Services
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 and PMAs. Michael Feldstein, Ph.D., Director Clinical Services, has over 30 years of experience in clinical trial design, conduct, and analysis, and manages a staff of project managers, monitors, statisticians, programmers, and data clerks. Read more about MDCI’s clinical services.
Quality Assurance & Compliance Services
Led by Judith Andrews, Ph.D., Manager of QA & Compliance, this 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.
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 European Medical Manufacturing Suppliers Directory:
- Consultants: Auditing/Inspections (67 companies)
- Consultants: Clinical research (28 companies)
- Consultants: Clinical trials management (42 companies)
- Consultants: Conformity assessment (43 companies)
- Consultants: Quality assurance/Quality systems (105 companies)
- Consultants: Registration/Submission assistance (53 companies)
- Consultants: Regulatory (105 companies)
- Consultants: Risk management (50 companies)
- Consultants: Technical documentation (72 companies)
- Consultants: Training services (84 companies)
