Your Medical Innovations, the FDA & Regulatory Strategy

Your Medical Innovations, the FDA and Regulatory Strategy As you strive to speed your innovations to the medical marketplace, it can feel challenging to explore development while also balancing US Food and Drug Administration (FDA) regulations. The good news is, it’s clear to see the FDA both wants to support industry innovations and advance discovery

By | 2017-11-20T14:34:44+00:00 November 20th, 2017|Managing Risk, Regulators|

The Importance of Organizational Risk Management in the Medical Technology World

Risk management is a vital planning step for any organization. Risk management involves identifying and minimizing potential risks for your company. It’s essentially the process of anticipating potential risks a company could face, and taking the necessary steps to reduce the possibility of them occurring. Risk management is important because it protects both your organization

By | 2017-08-10T12:13:26+00:00 August 8th, 2017|Medical Device Information, Regulators|

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|