MDCI Hires New Director of Regulatory and Clinical Services

Medical Device Consultants Inc. (MDCI), a regulatory consulting firm and contract research organization (CRO) serving the medical device industry, has hired Fred Tobia as director of regulatory and clinical services. He will oversee the daily operations of the company’s clinical and regulatory services groups, reporting to Vicki Anastasi, vice president of regulatory services and business development.

Tobia has more than 20 years of experience in the medical device and CRO industry and has held increasingly senior executive roles in regulatory, quality and clinical affairs at Alliant Medical Technologies Inc. (formerly UroMed), CareStat Inc., and Seacoast Technologies. For the past six years he was vice president of regulatory and clinical affairs at NMT Medical Inc. He has successfully gained clearance and approval of premarket approval applications, 510(k)s, investigational device exemptions, investigational new drug applications, new drug applications, biologics license applications, and international design dossiers with and without clinical data.

“I am excited to welcome Fred to MDCI,” said Anastasi. “His impressive track record of integrating worldwide regulatory, clinical and quality programs, along with a proven ability to manage the device development process from pre-clinical through post-market activities will serve our clients well.”

Tobia holds a bachelor of science in biology from Providence College and a certificate in public health from Harvard University School of Public Health.He has published numerous articles in peer-reviewed journals and is a recognized speaker and advisor with medical device industry trade and professional organizations, including U.S. Food and Drug Administration task forces.

Founded in 1980, MDCI is headquartered in North Attleboro, Mass.