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Helping public health practitioners conducting evaluations – developing a logic model to represent how your intervention works.
Information and guidance on a range of medical devices for users and patients.
DASA funding has helped Wales-based SME, Trauma Simulation develop a whole-body model for trauma training, from the point of wounding to damage control surgery
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
A cutting-edge trauma casualty simulation mannequin, invented and developed by a UK clinician and funded by the Ministry of Defence, has been used for the first time in a full-scale field hospital training exercise.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to create a model of how your digital health product works and choose measures for your evaluation.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
Advice for manufacturers of Class I medical devices for placing products on the UK market
Information about the EU Regulations and their implementation in Northern Ireland
How to conform with the legal requirements for placing medical devices on the market.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to use a patient-reported outcomes and experiences study to evaluate your digital health product.
Advice on writing clear notices and maximising replies to your FSNs.
Don’t include personal or financial information like your National Insurance number or credit card details.
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