News August 21, 2008 John Webster to Chair Session and Present on EU Regulatory Requirements for Medical Devices August 21, 2008, North Attleboro, MA – The Active Implantable Medical Devices Directive (AIMD), Medical Devices Directive (MDD), In Vitro Diagnostic Devices Directive (IVDD) and the CE Mark were developed to drive harmonization of regulatory requirements. But, … continue reading

News August 21, 2008 William Morton to Chair Session and Present on Global Harmonization Task Force (GHTF) Overview and Status August 21, 2008, North Attleboro, MA – The Global Harmonization Task Force (GHTF) was initiated in 1992 in an effort to achieve greater uniformity among national medical device regulatory systems. William Morton, President, Medical Device … continue reading

August 21, 2008, North Attleboro, MA – Early and systematic development of the optimal regulatory strategy can significantly reduce uncertainties in device development programs. For products whose regulatory requirements are unclear and where a clinical trial may be needed, a pre-IDE consultation with the US Food and Drug Administration could be a company’s most meaningful … continue reading

News August 18, 2008 William Morton and John Webster Selected as RAPS Fellows MDCI is pleased to announce that Bill Morton, President, and John Webster, Managing Director, MDCI International, Ltd., have been selected as Regulatory Affairs Professional Society (RAPS) Fellows. The RAPS Fellows program recognizes senior regulatory professionals for their continued significant contributions and leadership … continue reading

News June 23, 2008 MDCI Welcomes Jeff Roberts as Regulatory Consultant Jeff Roberts will provide regulatory and clinical trial guidance to medical device clients 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 … continue reading