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America Invents Act – How Will It Affect You?
Changes being made to the U.S. Patent system, will affect applications filed after March 16, 2013 and change the playing field for filing patents across the device sector – including large corporations, smaller companies and start-ups.
Testing for Two
Biocompatibility testing for combination products is complex and challenging, and, if not performed correctly, can have serious and costly consequences. This article identifies five major areas that a manufacturer about to embark on a program of biocompatibility testing should consider.
Combination Products: Two Case Studies
In continuation with the previous column
Combination Products 101
, here are two case studies that cover a device company’s perspective and a drug maker’s angle on ensuring regulatory compliance of their combination products.
Combination Products 101
Have something to ask about your Combination Product? Follow this Q&A series.
Drug-Device Combination Market – poised for attractive growth
Market estimated at $10.6 Billion; expected to grow at 11.8%
EDITOR'S CHOICE:
Devine Guidance: IVDD Article 16 – CE Marking
The regulatory gods in the EU like their CE Mark as is, so there is no need for improvement. In fact, the notified bodies are mostly in agreement (a rare event indeed) that there needs to be consistency in regards to CE mark construction and visibility.
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FEATURES
NEWS
Combination Products 101
Combination Products: Two Case Studies
Drug-Device Combination Market – poised for attractive growth
Testing for Two
“Repeal Medical Device Tax Immediately,” Boston Scientific CEO tells Congress
‘FDA Fails at Monitoring Device Safety’ says Report
FDA Addresses Reusable Medical Devices
Medtronic Sells Physio-Control to Bain Capital for $478M
U.K. Implant Danger Widespread
FDA Looking to Partner with Industry Groups
Device Ombudsman Lists Complaints
MEDdesign: Psychology in the Design of Medical Devices
Branding professionals and consumer product designers have known about the importance of psychology and self-expression for a long time; these aspects should be as important when designing medical devices.
Guide to selecting and using Light Curing Systems
Light curing technology has allowed manufacturers to lower processing costs, produce higher quality products and eliminate the use of harmful chemicals from the workplace for over 20 years. Although each manufacturer will perceive and realize a unique set of benefits from light curing, there...
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