Tailored consulting solutions for medical product development. Based on your requirements and individual challenges, we provide comprehensive consulting services for product development. In the course of your product’s development, we constantly focus on the product’s core features: its Target Product Profile (TPP), combining product features and goals for development.
Guiding your medical device journey, addressing your unique challenges and goals. In the complex landscape of medical device development, considerations about intended use, user and system requirements, regulatory pathways, quality and risk management, and post-market surveillance are critical. We offer extensive expertise and a robust network to navigate these challenges, ensuring your product meets regulatory standards and market demands.
A Target Product Profile, or TPP, is a document that is installed to facilitate the process that navigates toward the approval of an investigative drug product or medical device.
It is understood as a dynamic document that should be updated during the drug/device development process. To ensure this a TPP gives detailed and up-to-date information regarding the commercial and intended therapeutic goals of the product, in relation to the intended development plan that is needed to achieve these goals. In our experience, a TPP represents a realistic rather than an optimistic view of the goals of product development.
Market authorization – navigating the path to market access!
Classification of the medical device is always the first step on your way to get access to new markets. But even this first step isn’t always that easy since different countries apply different systems for classification. Furthermore, to proof the conformity most countries have different routes in the application process. We and our network of experts provide guidance through this sophisticated process.
