Regulatory and Compliance
Jul 12, 2017
Have notoriously long review times for device regulatory approval in Japan improved in recent years? An expert on the Japanese device market analyzes the...
Jul 10, 2017
Have notoriously long review times for device regulatory approval in Japan improved in recent years? An expert on the Japanese device market analyzes the...
Jun 23, 2017
A call to put patient safety at the top of the list of priorities for healthcare reform includes a directive for the medical device industry.   Jeffrey R...
Jun 22, 2017
Learn more about the landmark Supreme Court decision that has important implications for medical device manufacturers. Baldassare Vinti, Esq. Last month, the...
Jun 14, 2017
Legislation purporting to focus on the safety and effectiveness of medical equipment servicing is underway, but is there a problem with the quality of...
Jun 13, 2017
A recent Supreme Court ruling in a case involving toner cartridges for printers is important for manufacturers of single-use medical devices. Here's why....
Jun 09, 2017
Here are five key tips for medical device manufacturers planning to offer value-based discounting arrangements to health insurers. Meena Datta, JD Health...
Jun 05, 2017
Recent developments in patent law have made it more difficult to secure patent protection for certain technologies for healthy aging,  such as...
Jun 02, 2017
When companies jump too quickly to declare a corrective and preventive action is needed, "death by CAPA" occurs. Alex Butler For companies, bad things...
May 31, 2017
A regulatory expert discusses the most significant changes in the new European Medical Device Regulation that manufacturers will need to look out for and gives...