pharmaphorum6mon
MHRA's AI as medical device pilot opens for applicants
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has put out a call for developers of artificial intelligence as a medical device (AIaMD) technology to join its new regulatory ...
pharmaphorum28d
Are apps medical devices? Part one: what is the impact on pharma as the first app is registered as medical device with the MHRA?
The Mersey Burns app has just been launched on the iTunes Store and this is the first in the UK to be registered with the MHRA as a Class I medical device as per the EU Medical Device Directive.
University of Bristol3y
Medicines and Healthcare products Regulatory Agency (MHRA) review
The MHRA are required to inspect organisations conducting CTIMPs ... information to support the licensing (via CE mark / UKCA mark) or the marketing of a Medical Device. Often one of the most ...
Business Wire26d
C2N Diagnostics’ PrecivityAD2™ Blood Test Receives MHRA Medical Device Certification in the United Kingdom
today announced the medical device registration from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (UK MHRA) for the PrecivityAD2™ blood test. The PrecivityAD2 blood ...
MHRA issues urgent warning as thousands of counterfeit anti-choking devices sold across UK
Anti-choking devices work by suctioning out a blockage in a person's airway - but there are only two brands which have been ...
Hosted on MSN11mon
Medtech SMEs seek clearer legislation for device classification
The panel also discussed the UK Medicines and Healthcare products Regulatory Agency (MHRA)'s regulatory reform ... technologies like AI in both the medical device and pharmaceutical industries.