Speaker: Agneta Larhed, Senior regulatory consultant, RegSmart AB Uppsala
How do I prove that my 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 I use it 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 medicinal product, with a suitable quality, that can be approved by the regulatory authorities and meet the market needs?