There are too many unique needs on the part of both manufacturers and providers. More collaboration is needed.
Next month cybersecurity experts from FDA, medical device companies and other healthcare organizations with gather to talk strategy and best practices for designing and evaluating secure technologies.
Medical devices economic operators need to act fast to mitigate impacts of the UK withdrawal of EU in March 2019.
How software is changing the legal landscape for medical device manufacturers.
A manufacturing error could cause chamber parts to split into layers and cause water to back up into the patient breathing circuit.
SNITEM & Philips France vs. Health Minister: the ECJ defines the conditions under which software for assistance to the medical prescription can be qualified medical device within the meaning of the Directive.
The agency has issued its list of the most common inspectional observations for FY 2017.
Priorities include unique device identification and next-generation sequencing for in vitro diagnostics.
ECRI releases its top 10 list of health technology hazards for 2018.
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.