A medical device's intended purpose - what is the point?
How do you define intended purpose, indication for use, intended clinical benefits, and claims?
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Mantra Systems provides professional UK & EU MDR medical device regulatory consulting services to companies seeking compliance & market access for any class of medical device.
Our unique network of medically-trained consultants will bring unrivalled clinical evidence appraisal & analysis to your medical device regulation strategy.
Do it once and do it right with our training courses and fill-in-yourself templates. Gain confidence, reassurance & control over your EU MDR strategy.
Our Medical Device Regulation Resources contain information and guidance on a wide range of aspects across the regulatory landscape.
For further guidance or any specific enquiries, please contact our specialist consultants.
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How do you define intended purpose, indication for use, intended clinical benefits, and claims?
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We discuss the pros and cons of existing adverse event databases for vigilance data searching.