| Medical Device Consultants Inc. Press Release |  |
MDCI Welcomes Jeff Roberts as Regulatory Consultant
North Attleboro, MA, June 23, 2008 - Medical Device Consultants, Inc. (MDCI), a leading regulatory consulting firm and CRO for the medical device industry is pleased to welcome Jeffrey Roberts as Regulatory Consultant to its Massachusetts headquarters.
"Every day we speak with new and existing clients who are developing novel, exciting and innovative medical technologies. In response the continuing need for experienced and knowledgeable regulatory affairs and quality assurance support, MDCI is please to welcome Jeff to our team," said Vicki Anastasi, Director of Regulatory Services.
Jeff has over twelve years experience in medical device regulatory affairs and quality management. He works closely with medical device manufacturers and suppliers to address FDA premarket requirements and ongoing quality assurance for a wide range of medical devices and systems.
Prior to joining MDCI Jeff was Regulatory Affairs Manager at Candela Corporation, where he was responsible for the development, negotiation, and implementation of U.S. FDA and international regulatory strategies for Candela’s medical and aesthetic laser devices with indications for tattoo removal, hair removal and acne scar treatment. At Confluent Surgical, he managed FDA, EU and other international submissions for class II and class III absorbable implant medical devices with abdominal, cranial and spinal indications. Jeff also served as a Project Quality Engineer at Mitek Products / Johnson & Johnson, a leading developer and manufacturer of surgical sports medicine and soft tissue repair devices.
Jeff holds his B.S. in Mechanical Engineering Technology from Wentworth Institute of Technology in Boston, MA. He is a certified Quality Engineer and is a Regulatory Affairs Certification candidate.
About MDCI
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.
Visit www.mdci.com or call 1 508 643-0434 for more information.
