Failing to report serious patient injuries will win you a warning letter.
Economic development in China has created a burgeoning middle class that demands higher standards of living.
FDA expects all installation activities to be documented.
The President’s actions (or distractions) may be detrimental to Western medical device companies.
Document control is a critical part of your QMS.
The DMR is nothing more than the recipe (a.k.a. secret sauce), while the DHR is documented evidence of compliance.
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.
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.
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.
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.