The HEAT is on …

Yes, it is summer time for sure – but the HEAT in this instance is the “Health Care Fraud Prevention and Enforcement Action Team” initiative, which was announced in May 2009 by the Attorney General and the Secretary of Health and Human Services in order to combat health care fraud. Two recent enforcement actions against

By | 2017-08-08T21:57:46+00:00 July 28th, 2016|Regulators|

Update to EU’s Medical Device Clinical Evaluation Guidelines

In June, the European Commission released Revision 4 of MEDDEV 2.7/1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies, found amidst other guidance documents here. The release constitutes a major re-write of the previously issued guidance (found here), increasing the document from 46 to 65 pages of "how-to" conduct the Clinical Evaluation. Though not legally binding

By | 2017-08-08T21:55:54+00:00 July 6th, 2016|Compliance Updates & Legal Info|