The President’s actions (or distractions) may be detrimental to Western medical device companies.
ECRI releases its top 10 list of health technology hazards for 2018.
Recognizing that additive manufacturing is an emerging technology, the agency is providing an outline of its current thinking about the technical aspects of AM processes.
Effectively leveraging the intellectual assets of your business requires a holistic approach to IP protection.
With the increase of diabetes prevalence in Asia and the rise of Asia’s middle classes, the demand for newer and better treatments will provide opportunities for Western medtech companies.
There really is not much rocket science involved when attempting to determine the odds of a device establishment being awarded a prized agency warning letter when the establishment is on the receiving end of sixteen Form 483 observations during an inspection.
Medical Software Regulations in Asia 2017
As standalone software becomes increasingly sophisticated, a number of regulatory bodies have begun to draft separate guidelines to ensure quality control, expedite product approval, and improve patient access to new technologies.
There are usually only losers in patent litigation, so the best strategy is avoidance.
The doctor struggles to understand how the observation extracted from the warning letter referenced in this week’s guidance managed to rise to the level of a Form 483 Observation.
Sports Medicine in Asia 2017
Global sports medicine is predicted to grow to around $35 billion by 2022, with the Asian market growing at a compound annual growth rate of nearly 7 percent.