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How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to use an interrupted time series to evaluate your digital health product.
How to use a before-and-after study to evaluate your digital health product.
How to make sure that your products are properly checked for conformity and your technical documents are managed correctly.
How to begin with evaluating a digital health product, including when to evaluate, budgeting and getting support.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to get access to MHRA submissions portals, how to use them, where to go for help.
What animal by-products (ABPs) are, how to set up a site that uses them safely, the paperwork you need, and how to dispose of them.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
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