Guidance on how to report adverse incidents with biological/mechanical surgical heart valves. To be read in conjunction with the guidelines on a medical devices vigilance system MEDDEV 2.12/1.
We have previously published specific software guidance on medical device stand-alone software including apps.Types of software likely to be a medical device‘Software’ is defined as a set of instructions that…
See this poster for top 10 tips for point of care testing including:managementhealth and safetytrainingassuring quality
The Innovation Accelerator service will help provide innovators access to MHRA scientific expertise and regulatory guidance, helping developers of innovative products (medicines, medical devices (including software) and blood components for…
RamaXL is a subscription service providing organisations with direct access to information on their own products and non-confidential information on all other products authorised in the UK.Its features include:access to…
