MDCI's 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.

Review staff biographies

Review our product experience

Our staff participates frequently in seminars, workshops, and other industry sponsored presentations. Browse the links on for a list of upcoming events and to review a summary staff publications.

MDCI also offers customized in-house seminars or training courses on any aspect of FDA regulation of medical devices or diagnostic products.

MDCI expert consultants will

customize presentations to meet your special training needs

involve participants to maximize the learning experience

perform training sessions at your convenience for staff at your facility

Sample topics include:

Overview of Medical Device Regulations

IDE Regulations and Clinical Study Applications

How to Draft an Effective Informed Consent

FDA Enforcement Activities

FDA Requlatory Requirements for Software Documentation

Comparison of FDA ISO 14155 Requirements for Medical Device Clinical Studies

Performing Clinical Investigations to Meet Medical Device Regulatory Requirements

Speak with a Consultant

Reach our Massachusetts office at 1-508-643-0434, Monday through Friday, 9:00 a.m. to 5:00 p.m. Eastern. Or click here and a consultant will contact you directly.