Regulatory
Meeting Regulatory Requirements with FEA
I recently returned from a workshop on Computer Methods for Cardiovascular Devices sponsored by the Federal Drug Administration, the National Heart, Lung, and Blood Institute, and the National Science Foundation
Study confirms device tax could cost jobs, stifle innovation
The medical device tax, if implemented, could cost tens of thousands of jobs, almost double the industry’s total taxes, raise the effective tax rate to among the highest in the world, and harm US competiveness, according to a study released today by AdvaMed...
Clinical trials in the cloud
Clinical trial image management for medical devices has come a long way and cloud computing is now taking it even further....
AdvaMed cautions CMS
The Centers for Medicare & Medicaid Services (CMS) recently announced plans to expand its Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program....
America, it’s time for a medtech competitiveness agenda
America’s medical manufacturing success story now faces challenges like never making this the time for a medtech competitiveness agenda...
FDA Boot Camp
Medical device makers will have an opportunity to learn the ins and outs of the FDA regulatory process and structure during the American Conference Institute’s FDA Boot Camp Devices Edition conference, Oct 25 and 26, in Chicago...
Medtronic engages Yale to oversee reviews of its Infuse bone graft
Device giant Medtronic has set in motion the first of its kind post-review Web site of a medical product...
America, it’s time for a medtech competitiveness agenda
America’s medical manufacturing success story now faces challenges like never making this the time for a medtech competitiveness agenda...
FDA issues draft guidance for mobile medical applications
FDA has issued a draft guidance for the development and implementation of mobile applications for smart technology devices...
Congress continues to examine medical device approval process
The Subcommittee on Oversight and Investigations today held a hearing titled “Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs” to examine the state of the medical device industry and the impact regulations and policies at CDRH have on patient access, innovation, and job creation...
FineLine gains ISO
FineLine Prototyping, Raleigh, NC, is now ISO 9001:2008 registered...
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