You may think that intended purpose and MDR classification are simply regulatory requirements that need to be defined before development can move forward. In reality, these decisions have far-reaching implications. They can influence clinical evidence requirements, development priorities, regulatory pathways, claims and ultimately the commercial potential of a medical device.
The challenge is that these decisions are often made incrementally rather than as part of a deliberate strategy. Product objectives, claims and classification can evolve through a series of individual decisions, making it difficult to understand their combined impact.
In this 60-minute complimentary webinar, our expert will explore two hypothetical medical device software applications built on similar technology but designed for different intended purposes. Through these examples, participants will see how different approaches can lead to different evidence expectations, regulatory pathways and product positioning opportunities.
Format: 60-minute live webinar with practical examples, expert discussion and Q&A
Language: English
Speakers: Malte Knowles Schmidt
Intended purpose is not simply a regulatory statement. It is a foundational element that influences your commercial potential and many decisions throughout the product lifecycle.
After attending this webinar, you will be better equipped to:
This webinar is designed for early-stage MedTech companies and professionals involved in product development, regulatory planning and investment decision-making.
It is particularly relevant for:
This webinar is especially useful if you are:
Malte Knowles Schmidt - Global Portfolio Manager, TÜV SÜD Medical Health Services
With experience supporting MedTech innovation and market access initiatives, Malte helps connect regulatory considerations with business objectives. In this webinar, he will share how intended purpose can influence regulatory pathways, evidence expectations and commercial opportunities.
This webinar is in a three-part series focused on helping MedTech organisations understand how regulatory decisions can be used as a business asset, not a blocker throughout their development journey.
This webinar forms part of TÜV SÜD's broader Start-up & Investors Initiative, designed to help MedTech startups and investors better understand regulatory considerations that may influence product development, investment readiness and commercialisation planning.
