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How to ensure the products you make or import comply with the law and are safe for consumers to use.
How a product complies with EU safety, health and environmental requirements, and how to place a CE marking on your product.
How to use usability testing to evaluate your digital health product.
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.
How to begin with evaluating a digital health product, including when to evaluate, budgeting and getting support.
Your purchasing strategy must show you’ve considered commercial and technology aspects, and contractual limitations.
Information for manufacturers.
Information on cleaning an oil spill including your options, how to get a product approved and how long it will take.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Results from the OPSS online marketplace product testing programme for October 2021 to September 2022.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
How to use an interrupted time series to evaluate your digital health product.
Proficiency testing (PT), also known as external quality assessment (EQA), allows the introduction of samples of known but undisclosed content into a laboratory’s routine testing procedure.
How to use a quasi-experimental study to evaluate your digital health product.
How to use an ethnographic study to evaluate your digital health product.
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