Description
You will learn from ex-regulators how regulators think, and we will guide you through the regulatory landscape. After the seminar, you will have a clearer understanding of how to turn your research into efficient product development, always with the end in mind.
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Learn more about:
How to take your product to the market, you have to decide what kind of product it is, i.e. which regulatory framework to follow. Why this is important and how to choose.
How do you prove that your medical device complies with the regulations? The concepts of safety and efficacy as well as risk/benefit assessment, and a brief note on quality management systems – why and when? What is a clinical evaluation, and how can it be used to add value in my product development?
Learn more about how to take advantage of establishing a TPP, target Product Profile, early in the development. How do you plan your development program to obtain an effective and safe product, with suitable quality, that can be approved by the regulatory authorities and meet the market needs?
Training seminar in regulatory knowledge – EATRIS
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