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FDA to Modernize the 510(k) Program to Enhance the Safety and Effectiveness of Medical Devices

on Dec 13, 2018 12:23:00 PM By | Craig Cook | 0 Comments | Medical Device Manufacturing
On November 26, 2018, the FDA announced changes to its 510(k) clearance pathway for medical devices. The statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health (CDRH), proposes to modernize the 42 year old method for evaluating the safety and effectiveness of most approved medical devices.
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Blockbuster International Report Rocks Medical Device Industry

A nearly year-long international investigation into medical device safety by 252 journalists from 36 countries representing 59 media partners has concluded. The intense examination looked into how medical devices are tested, approved and monitored by various regulatory agencies. The results will forever change the world of medical device manufacturing.
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NetSuite Enables Medical Device Manufacturers To Comply With Labeling Regulations

The primary objective of Medical Device labeling is to ensure that patients in need, and practitioners providing care, can access clear, accurate and understandable instructions for use. But medical device labels serve many other important purposes, and as such, are closely regulated by the FDA. Today, medical device manufacturers continually strain resources in pursuit of FDA Label Requirement compliance. They are feeling the pressure and taking a more comprehensive look at managing complex labeling needs.
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